Guidance for Industry
Guidance for the Submission of
Premarket Notifications for
Emission Computed Tomography
Devices and Accessories
(SPECT and PET) and Nuclear
Tomography Systems
Document issued on: December 3, 1998
U.S. Department Of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Radiological Devices Branch
Division of Reproductive; Abdominal; Ear, Nose, and Throat;
And Radiological Devices
Office of Device Evaluation Preface
Public Comment
       Comments and suggestions may be submitted at any time for Agency consideration
to, Robert Phillips, Ph.D., Chief, Conventional and Therapeutic Radiological
Devices Branch, HFZ-470, 9200 Corporate BLVD., Rockville, MD 20850.
Comments may not be acted upon by the Agency until the document is next
revised or updated. For questions regarding the use or interpretation of this
guidance contact Andrew Kang, MD at (301) 594-5072 ext.148 or by e-mail at
sak@cdrh.fda.gov. 
Additional Copies
World Wide Web CDRH home page: http://www.fda.gov/cdrh/ode/2240.pdf, or
CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number
2240 when prompted for the document shelf number.
2 Table of Contents
Page
I.  Purpose  5
 
II.  Scope  5
III.  Background  5
IV.  Regulatory Requirements  5
V.  The New 510(k) Paradigm  6
A.  Special 510(k)  6
B.  Abbreviated 510(k)  6
VI.  Standards for Emission Computerized Tomography (ECT) Devices 7
A.  NEMA Performance Standards  7
B.  Other Standards  7
VII.  General Information Required in a Premarket Notification  8
A.  General  8
B.  Administrative  8
C.  Device Description  8
D.  Software  9
E.  Year 2000 Compliance  9
F.  Electrical, Mechanical Safety  9
G.  Labeling  9
      
VIII  Single Photon Emission Computerized Tomography (SPECT)  11
A.  Definition  11
B.  Device Description  11
C.  Comparison with the Predicate Device(s)  12
D.  Performance  12
E.  Hazard Analysis  12
F.  Clinical Images  13
3 VIII-1 511 keV Ultra-High Energy Collimators (UHEC)  13
A.  Definition  13
B.  Background  13
C.  Device Description  13
D.  System Performance  13
E.  Comparison with the Predicate Device(s)  13
F.  Mechanical Safety Data  14
G.  Clinical Images  14
H.  Labeling  14
VIII-2 Attenuation Correction Device (ACD) for SPECT  15
A.  Definition  15
B.  Device Description  15
C.  Comparison with the Predicate Device(s)  15
D.  Bench Tests  16
E.  Hazard Analysis  16
F.  Clinical Images  16
G.  Additional Labeling  16
IX  Positron Emission Tomography (PET)  17
A.  Definition  17
B.  Device Description  17
C.  Bench Tests  18
D.  Comparison with the Predicate Device(s)  19
E.  Hazard Analysis  19
F.  Clinical Images  19
X.  Coincidence Imaging Device (CID)  20
A.  Definition  20
B.  Device Description  20
C.  Other Information  20
XI.  Nuclear Tomography Systems  21
A.  Definition  21
B.  Device Status  21
Appendix
1.  Declaration of Conformity  22
2.  510(k) Summary/Statement Certification  23
3.  Indications for Use Form  24
4.  Premarket Notification Truthful and Accurate Statement  25
4 I. Purpose
The purpose of this guidance document is to provide a detailed description of the information that
should be included in a premarket (510(k)) notification for an emission computed tomography
diagnostic device or nuclear tomography system submitted to the Center for Devices and
Radiological Health (CDRH).  This information is an elaboration of the general requirements
contained in 21 CFR 807.87.
II. Scope
The scope of this document encompasses Emission Computed Tomography Systems as defined in
21 CFR 892.1200 and Nuclear Tomography Systems as defined in 21 CFR 892.1310.
An emission computed tomography system is a device intended to detect the location and
distribution of gamma ray- and positron- emitting radionuclides in the body and produce cross-
sectional images through computer reconstruction of the data
A nuclear tomography system is a device intended to detect nuclear radiation in the body and
produce images of a specific cross-sectional plane of the body by blurring or eliminating detail
from the other planes.
This includes Single Photon Emission Tomography (SPECT) imaging systems and their accessory
devices, 511 keV Ultra-High Energy collimators (UHEC), Attenuation Correction Devices
(ACD), Positron Emission Tomography (PET) imaging systems and their accessories,
Coincidence Imaging Devices (CID), and Nuclear Tomography Systems (NTS) and its
accessories.
III. Background
A number of legislative changes relating to the authority of the agency have occurred. These changes
have resulted in the adoption of new regulations and administrative procedures by CDRH which affect
the 510(k) process. The Safe Medical Devices Act of 1990 (SMDA) has resulted in New Good
Manufacturing Practice (GMP) regulations requiring pre-production design controls, and several
administrative requirements (Summaries of Safety and Effectiveness, and Statements of Indications for
Use) have been added. The Food and Drug Administration Modernization Act (FDAMA) of 1997 and a
re-engineering effort have resulted in the development of a new 510(k) paradigm, which incorporates
alternative approaches to demonstrating substantial equivalence in premarket notifications. These
approaches are intended to facilitate the marketing clearance of devices, such as SPECT or PET devices,
for which recognized standards exist, and for cases in which the new device is a modification of a
previously cleared product.
IV. Regulatory Requirements
Under the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act of 1976, all
Emission Computed Tomography (ECT) and their accessory devices may be cleared by 510(k)
process, when the device shows substantial equivalence to the legally marketed predicate devices.
5 All Emission Computed Tomography devices and accessories are currently classified as Class II
devices with a Product Code of 90-KPS.  Nuclear Tomography Systems are classified Class II
with a product code of JWM.
V.  The New 510(k) Paradigm
On March 20, 1998 CDRH issued a document entitled The New 510(k) Paradigm - Alternative
Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.  This document is
available on the CDRH web site (http://www.fda.gov/cdrh/ode/parad510.html).  In addition to the
traditional 510(k), this document describes two alternatives, the Special 510(k): Device Modification
and the Abbreviated 510(k).
A.  Special 510(k)
The Special 510(k) is based on the requirement that manufacturers establish design controls in
accordance with the SMDA and 21 CFR 820.30. A manufacturer uses the FDA guidance
document entitled Deciding When to Submit a 510(k) for a Change to an Existing Device to
decide if a device modification could be implemented without submission of a new 510(k). If a
new 510(k) is needed, and if the modification does not affect the intended use of the device or the
basic fundamental scientific technology, conformance with design controls may form the basis for
clearing the application. Under this option, a manufacturer who is intending to modify a legally
marketed Class II device would conduct the necessary verification and validation activities to
demonstrate that the design output of the modified device meets the design requirements. Once
the company has ensured the satisfactory completion of this process through a design review, a
Special 510(k) may be submitted. While the basic content requirements for the submission are the
same, this type of submission should also reference the cleared 510(k) and contain a Declaration
of Conformity with design control requirements. In the Special 510(k) the manufacturer has the
option of using a third party to assess conformance with design controls (refer to the paradigm
document for details). Special 510(k)s are to be processed by the Office of Device Evaluation
within 30 days of receipt by the Document Mail Center.
B.  Abbreviated 510(k)s
The Abbreviated 510(k) is based on the use of conformance to voluntary standards in place of
data review as the means by which the safety and effectiveness of Class II devices can be assured.
Manufacturers may submit an Abbreviated 510(k) when FDA has recognized an individual or
several voluntary standards that cover aspects of the new device. In addition to the required
elements of a 510(k) as described in 21 CFR 808.87, Abbreviated 510(k) submissions should
include information that describes how conformance to one or several voluntary standards,
recognized by CDRH, have been used to address risks associated with the device, and a
Declaration of Conformity to those standards. The Declaration of Conformity should provide
the information listed in the paradigm. A third party may be used to assess conformance with
these standards (refer to the paradigm document for details). The review of abbreviated 510(k)s is
intended to be more efficient since they are not required to contain the experimental data from
which conformance is determined.
6 VI. Standards for Emission Computed Tomography (ECT) Devices
The Food and Drug Administration Modernization Act of 1997 authorizes CDRH to recognize
consensus standards established by national and international standards development
organizations that may be used to satisfy identified portions of device review requirements. On
February 19, 1998 CDRH issued a Guidance on the Recognition and Use of Consensus
Standards which is intended to provide information relating to the recognition and use of
national and international consensus standards. It is available on the CDRH web site
(hhtp://www.fda.gov/cdrh/modact/k982.html),  and describes how the agency will use information
on conformance with recognized standards to satisfy premarket review requirements. It also
describes the content of a declaration of conformity. In the case of 510(k)s, information on
conformance with recognized standards might help establish the substantial equivalence of a new
device to a legally marketed predicate in the areas covered by the standards. If a premarket
notification contains declarations of conformity, this will in most cases eliminate the need to
review the actual test data for those aspects of the device addressed by the standards. However,
the results of testing are expected when the standard specifies a test method without the
associated performance limits, as in the case of the NEMA standards discussed below.
A. NEMA Performance Standards
The NEMA standards NU 1and NU 2 are recognized by CDRH and thus may be used in
Abbreviated 510(k)s for emission tomographic diagnostic devices. They provide standardized
methods for measuring performance parameters for and gamma cameras (SPECT) and positron
cameras (PET).  To the extent possible, these methods should be utilized in traditional as well as
abbreviated 510(k)s.  The NEMA standards are:
NU 1 ---- Performance Measurements of Scintillation Cameras (1994)
NU 2 ---- Performance Measurements of Positron Emission Tomographs (1994)
It is important to recognize that the NEMA standards only prescribe standard measurement
methods. They do not specify acceptable levels of performance or safety. Acceptable levels of
performance are assessed by a comparison to previously cleared devices, on a case-by-case basis,
depending upon intended use, and the substantial equivalence criterion.
B. Other Standards
Levels of electrical and mechanical safety parameters are addressed by other standards discussed
below.  These standards are also recognized by CDRH.
IEC 60601-1, International Electrotechnical Commission, Medical Electrical Equipment,
Part 1: General Requirements for Safety
7 IEC 60601-1-2, Requirements for safety; Electromagnetic Compatibility  Requirements
and Tests
EN 1441 (1997), Medical Devices  Risk Analysis
UL 544, Standards for Medical, Dental Equipment, 3rd edition
UL 2601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety (This
is the UL version of IEC 60601-1).
NEMA PS3, DICOM (Digital Imaging and Communications in Medicine) (set includes
PS3-1 through PS3-13) -- This standard specifies formats for the exchange of radiology
and other medical images.
VII. General Information to be Submitted in  a Premarket Notification
General information to satisfy 21 CFR 807.87 for premarket notification submissions is listed and
discussed in detail below. This applies to all devices covered in this guidance along with the
specific requirements listed under the specific device sections.
A. General
Name and address of manufacturer.
Establishment registration number (if not available, registration application should be
submitted).
Name, title, phone number, fax number and E-mail of contact.
Trade name, model number, and common name of device.
Type of submission (special, abbreviated or traditional)
Classification and class of device (21 CFR 892.1200, class II), and product code (90-KPS)
Intended use (general purpose of device per 21 CFR 892.1200)
Applicable standards (e.g. NEMA, IEC or other standards).
B. Administrative Information
510(k) Summary of Safety and Effectiveness or Statement (see 21 CFR 807.92 and
807.93)
FDA Indications for Use Form (specific diagnostic use of device, i.e. the anatomical
region and/or disease/condition which the device is intended to diagnose)
Truthful and Accurate Statement (see 21 CFR 807.87(j))
Declarations of Conformity to Consensus Standards (Abbreviated 510(k) only)
Declaration of Conformity to Design Controls (Special 510(k) only)
C. Device Description
Refer to each specific device section.
  
8 D.  Software
Software used for ECT devices, in image acquisition, processing, creation of patients database or
image transmission, are of a moderate level of concern, as described in Guidance for the Content
of Premarket Submissions for Software Contained in Medical Devices (CDRH, 1998).
The following lists, in general, the software information that should be included is a submission:
The level of concern
A software description, including version number
Device hazard analysis
Software requirements specifications
Architecture design chart
Design specifications
Traceability analysis
Summary of the software life cycle development plan, including configuration
management and maintenance activities)
Description of Validation, Verification, and Testing activities at the unit, integration and 
  system level.  System level test protocol including pass/fail criteria and test results.
Revision history log
List of errors and bugs that remain in the device and an explanation how they were
determined not to impact safety and effectiveness, including operator usage and
human factors
E.  Year 2000 Compliance
Until January 1, 2000, specify whether the device is Year 2000 compliant.  Describe the
method(s) used for making this determination.
F.  Electrical, Mechanical Safety 
Provide information to establish the safety (electrical, mechanical, thermal, etc.) of your
device.  This may be either a Declaration of Conformity to FDA recognized standard(s), data
following an unrecognized standard together with a rationale for its use, or complete data and
a description of the testing methodology.
G.  Labeling
Following labeling recommendations apply to all Emission Computed Tomography (ECT)
devices, in addition to the specific labeling recommendations discussed under the specific device
sections.  The labeling for a ETC device should consist of Essential Prescribing information  (see
Medical Device Labeling --Suggested Format and Content,
http://www.fda.gov/cdrh/ode/labeling.html#epi), specifications (i.e. a product data sheet),
promotional material, and instructions for use (operators manual).
9 1.  Essential Prescribing Information (EPI) Consists of:
a.  a brief device description;
b.  intended use / indications;
c.  contraindications, warnings, precautions;
d.  adverse events;
e.  conformance to standards;
f.  operator's manual -- brief description    
i.  maintaining device effectiveness    
ii.  complete device description  
iii.  directions for use
g.  summary of recommended quality control method(s); on daily, weekly, or
quarterly bases;
h.  summary of  recommended maintenance schedules for the equipment,
including a designation of whether they should be performed by the  user or
company service personnel;
i.  summary of or reference to NRC requirements for radioisotope handling
(when a radioisotope is installed in the device permanently or transiently
for imaging purposes);
j.  references
2. Summary Specification Sheet
Provide a listing of the device specifications.
3.  Promotional Material (Product Data Sheet)
Claims contained in the promotional material should be consistent with the
statements in the FDA Indications for Use form.
4.  Users Manual
Complete instructions for the use of the device.
10 VIII. Single Photon Emission Computed Tomography (SPECT)
A. Definition
Single Photon Emission Computed Tomography (SPECT) devices are intended to detect gamma
radiation events and produce tomographic images that reflect the distribution of a
radiopharmaceutical in the body or individual organs.  [Devices capable of detecting coincidence
events of 511 keV photons are not included in this section; refer to Section C. Coincidence
Imaging Devices (CID)].
B. Device Description
The device description should contain the following information.
1.  A list of major components of the system and their purpose, including the number
of the detector heads, gantry, patients table, and acquisition and processing work
station with related interfacing software.
2.  A description of the basic design principles of gamma detection and image
production methods used, the unique features of the system, and the similarities to,
and the differences from the predicate device, in regard to the energy source,
performance characteristics, and the patient's safety. (e.g., describe the type of
crystal used, conventional NaI crystal vs. solid state semiconductor (CdTe) unit
(or other type of crystals); the photomultiplier tubes (PMT), the image acquisition
mode, the image processing method and algorithms, the interface software, the
energy range of photon detection, the image storage and retrieval, the gantry
design, collimators, patients table, and a built-in radioactive scanning source
housing, if there is one).
3. A description of the following:
a.  Detector ---- physical characteristics of the detector, including the shape
and the size of a detector head, FOV, number of crystal, or other gamma
detecting unit, and the thickness of the crystal, the shape and number of
PMTs.
b.  System Gantry ----the physical dimensions, partial and overall weight,
functional design, stability, mobility, safety features.
c.  Patients table ---- the overall dimensions, design characteristics, material,
weight limitation, safety features.
d.  Collimators ---- the number of collimators included, model numbers,
weight of each collimator, collimator mounting accessories and safety
features.   
e.  Collimator storage and exchange cart ---- the collimator storage unit and
the method of collimator exchange. (manual, automatic, etc).
f.  Image Acquisition and processing work station ----- the workstation, e.g.;
integrated, acquisition or processing only, universal or domain.
11 g.  Software; acquisition, processing, and networking ---- acquisition software,
reconstruction methods; FBJ (filtered Back Projection), or iterative,
processing software, 3rd party software, networking interface method,
h.  Other accessory devices ----- display monitors, hand-held or wireless
remote control unit, laser-positioning device, image storage and other
hardware and software.
i.  Functional characteristics, e.g.; simultaneous, dual isotope, triple window
imaging, whole body capability, analog, or digital signal processing with
ADC (Analog to Digital Converter), body contouring, etc. 
 4.  Photograph(s) showing the front, side and top view(s) of the device and summary
diagrams or drawings showing the dimensions of major parts and components and
describing the connections between the various components.
C.  Comparison of the New and Predicate Device(s)
A 510(k) submission is a comparison of a new device to a predicate to show that the two devices
are substantially equivalent.  Therefore, the sponsor must identify at least one class II legally
marketed device to which equivalence is claimed and compare the device to the predicate in terms
of design, performance, and functional and physical specifications.  Any significant differences
should be explained and a rationale given for substantial equivalence. 
D.  Performance
The performance characteristics of the system should be provided.  These should include:
intrinsic spatial resolution in FWHM at the surface and at 10 cm;
spatial energy resolution;
spatial linearity;
flood field uniformity;
count rate sensitivity; and
isolation of the detector to background.
Performance test data should be obtained using a NEMA NU1 phantom or an equivalent, under
the NEMA or equivalent performance standard test procedures.  Describe, in detail, alternate
methods and phantoms and provide a rationale for the acceptability of these alternates.
E.  Hazard Analysis
In tabular form, summarize the potential hazards (electrical, mechanical, radiation, software, etc.)
associated with the device and describe the methods used to mitigate them.  (This is not needed if
it is provided in the software section).
12 F. Clinical Images
Provide sample images from three clinical cases (may be from three different procedures), using
the subject SPECT device.  
VIII-1  511 keV Ultra-High Energy Collimators (UHEC) for SPECT
A. Definition
A 511 keV UHEC is an accessory device to a SPECT system that enables it to effectively detect and
image 511 keV photons.
B Background
In January 1997,CDRH issued a letter announcing the agencys decision to allow 511 keV collimators to
be cleared for market by the 510(k) process.
C.    Device Description
Provide a description of the collimator including the hole diameter, septal thickness, hole length, number
of holes, dimensions, detector shielding, collimator weight, the total weight of all collimators on the
system (i.e. triple detector devices usually use three collimators, the collimator supporting mechanism,
mechanical safeguards, collimator storage device and the collimator changing procedure.
D. System Performance
The performance characteristics of the system with the collimator(s) should be provided and
include:
intrinsic spatial resolution in FWHM at the surface and at 10 cm;
spatial energy resolution;
spatial linearity;
flood field uniformity;
count rate sensitivity; and
isolation of the detector from background.
Performance test data should be obtained using a NEMA NU1 phantom or an equivalent, under
the NEMA or equivalent performance standard test procedures.  Describe, in detail, alternate
methods and phantoms and provide a rationale for the acceptability of these alternates.
E.  Comparison with the Predicate Device(s)
A 510(k) submission is a comparison of a new device to a predicate to show that the two devices are
substantially equivalent.  Therefore, the sponsor must identify at least one class II legally marketed device
to which equivalence is claimed and compare the device to the predicate in terms of design, performance,
13 and functional and physical specifications.  Any significant differences should be explained and a rationale
given for substantial equivalence.
F.  Mechanical Safety Data
1. Provide a detailed description and drawing of the collimator mounting assembly to
the detector head for each model of camera system that the collimator is intended to
fit.  Provide the design safety factor of the mounting assembly that supports
collimator weight.
2. Provide data showing that the system can safely support the weight of the collimator(s). 
Describe the test procedures used to determine this.
3. If upgrading an existing system to accommodate the 511 keV collimator(s),
provide the results of and describe the test procedures used to ensure the safety of
the old system with the new collimator(s) installed.
G. Clinical Images
Submit sample images from three different organs, such as brain, lung, and heart, obtained on each
system used with the collimator.
H. Labeling
   
1. For an add-on collimator, for each system intended to be used with the
collimator(s), provide the system name, model number, and list the performance
specifications for the 511-keV collimator (see part D, this section).
2. Include a brief precautionary statement on the limited spatial resolution of the 511
keV collimator, such as the following.
Caution: The minimum spatial resolution on this system using 511-keV collimator
is __ mm. (Fill the blank with the devices measured resolution).  The spatial
resolution of 511 keV collimator is generally not as good as that of a typical PET
imaging system.
3. Include a warning that the system should only be used with FDA approved
radiopharmaceuticals.
14 VIII-2.   Attenuation Correction Device (ACD) for SPECT
A.  Definition
An Attenuation Correction Device for SPECT is an accessory intended to correct or minimize the
distortion caused by false information in emission computed tomographic images due to overlying
tissue or undesired scatter photons.
The indication statement should include the specific trade name of the ACD and the name and
model number of the camera system(s) that the ACD is intended to be used with.  The statement
should also specify whether it includes scatter correction capability.
B.  Device Description
1.  Provide a description of the ACD including the method(s) of the attenuation
correction (fan beam, parallel beam, or multiple line array, fixed or scanning
beam(s)), the method of scatter correction (split energy windows (or triple energy
windows, TEW) or pixel by pixel correction). It should also specify the number of
the ACD devices in a system, and provide a detailed description of the
components, acquisition methods (sequential or simultaneous acquisition of
emission and transmission images), and the image reconstruction algorithm (such
as; MLEM or OSEM, FBP, or iterative).  Also include a description of
transmission source, the source housing, the radiation and other safety features,
and other physical, functional specifications of the device.  The transmission source
description should include the type of source (isotope), the amount of
radioactivity, and descriptions of the source housing, safety features of the
housing, the shutter, and shielding.
2.  Submit a photograph, drawing, or diagram of the ACD, showing its dimensions,
the source housing, the detector head and the connection with the ACD assembly.
 Describe of the material used, the design and the construction of the housing and
comment on the related safety issues.
C.  Comparison with the Predicate Device(s)
A 510(k) submission is a comparison of a new device to a predicate to show that the two devices are
substantially equivalent.  Therefore, the sponsor must identify at least one class II legally marketed device
to which equivalence is claimed and compare the device to the predicate in terms of design, performance,
and functional and physical specifications.  Any significant differences should be explained and a rationale
given for substantial equivalence.
15 D.  Bench Tests
1.  Radiation measurements
a.  Provide the leakage radiation rates from source housing measured with the
source in the OFF position.  Describe the methods and equipment used
to do these measurements or provide a declaration of conformity to a
recognized methodological standard (e.g., NRC guideline for measurement
of leak rate of a radioactive sealed source or NCRP Report 102).  Leakage
rates, less than 2 mGy/h (200 mrad/h) at 5 cm from the surface of the
source housing, and less than 20 m Gy/h (2 mrad/h) at 1 m from the source
are acceptable range.
b.  Provide an estimate of the patient radiation exposure dose from the
transmission source for a typical clinical procedure.
3.  Using NEMA NU 1, SPECT phantom or an equivalent phantom, provide
comparison data and images with and without the use of ACD.  Also provide
comparison data for uniformity, attenuation map generation, and spatial resolution.
E.   Hazard Analysis
In tabular form, summarize the potential hazards (electrical, mechanical, radiation, software, etc.)
associated with the device and describe the methods used to mitigate them.  (This is not needed if
it is provided in the software section).
G.  Clinical Images
Submit images from three clinical studies obtained with and without using ACD.
H.  Additional Labeling
The source replacement procedure should be thoroughly described in the users manual, including
the wipe test procedure according to the NRC Guideline or equivalent.
16 IX. Positron Emission Tomography (PET) System
A Definition
Positron Emission Tomography (PET) devices are intended to detect, using coincidence detection
circuitry, 511 keV gamma radiation events, and produce tomographic images that reflect the
distribution of a positron emitting radiopharmaceutical in the body or individual organs.
B. Device Description
The device description should contain descriptions of the general design and functional
characteristics of the system.   It should include the devices trade name, model number, a list of
components, a description of the physical, functional, and performance characteristics of each
component, a description of the patient and user safety features, and the similarities and
differences from the predicate device(s).
1. The following should be described in detail:
a.  Detector unit --- Descriptions should include the type of scintillator ( NaI,
BGO, CsF, LSO, etc.); the number,  size, thickness of the scintillator and 
PMTs; and the cooling system.  Provide the general or measured
performance characteristics.
b.  Gantry System ---- Describe the physical and functional characteristics of
the gantry; e.g., dimensions, design principles, whether it is a rotating ring
gantry or multi-detector gantry system, and patient safety features.
c.  Patient table ---- Provide physical dimensions, functional characteristics,
patient weight limitation, and safety features.
d.  Transmission source ---- Provide the name of the isotope and the amount
of radioactivity.  Provide a physical description of the source housing and a
description of its safety features.
e.  Computer workstation and software ---- Describe the computer
workstation, acquisition software, reconstruction algorithms (e.g., OSEM
(Ordered Subset Expectation Maximization), FBJ (filtered Back
Projection), iterative reconstruction, etc.), 3rd party software, networking
software, and interfacing method.
f.  Other accessory devices ----- Describe display monitors, hand-held or
wireless remote control units, laser positioning devices, image storage and
other hardware and software.
17 4.  Provide photograph(s) showing the front, side and top view(s) of the device and
summary diagrams or drawings showing the dimensions of major parts and
components and describing the connections between the various components.
C. Bench Tests
1. Radiation measurements
a. Provide the leakage radiation rates from source housing measured with the
source in the OFF position.  Describe the methods and equipment used
to do these measurements or provide a declaration of conformity to a
recognized methodological standard (e.g., NRC guideline for measurement
of leak rate of a radioactive sealed source or NCRP Report 102).  Leakage
rates less than 2 mGy/h (200 mrad/h) at 5 cm from the surface of the
source housing, and less than 20 uGy/h (2 mrad/h) at 1 m from the source
are acceptable.
b. Provide an estimate of the patient radiation exposure dose from the
transmission source for a typical clinical procedure.
2.  System performance
The performance characteristics of the system should be provided and include:
intrinsic spatial resolution in FWHM at the surface and at 10 cm;
energy resolution;
transverse and axial resolutions
spatial linearity;
flood field uniformity;
the system sensitivity,
coincidence timing window,
coincidence dead time,
scatter fraction,
scatter correction method,
slice thickness, 
count rate sensitivity; and
isolation of the detector from background.
Performance test data, should be obtained using a NEMA NU2 phantom, or an
equivalent, under the NEMA or equivalent performance standard test procedures. 
Describe, in detail, alternate methods and phantoms and provide a rationale for the
18 acceptability of these alternates.  Results should be reported in the same units as
specified in the NEMA standard.
D.  Comparison of the new and predicate device(s)
A 510(k) submission is a comparison of a new device to a predicate to show that the two devices
are substantially equivalent.  Therefore, the sponsor must identify at least one class II legally
marketed device to which equivalence is claimed and compare the device to the predicate in terms
of design, performance, and functional and physical specifications.  Any significant differences
should be explained and a rationale given for substantial equivalence. 
.
E.  Hazard Analysis
In tabular form, summarize the potential hazards (electrical, mechanical, radiation, software, etc.)
associated with the device and describe the methods used to mitigate them.  (This is not needed if
it is provided in the software section).
F.  Clinical Images
Provide sample images from three clinical cases using the submitted PET device.  
       
19 X.  Coincidence Imaging Devices (CID)
A.  Definition
A Coincidence Imaging Device is a SPECT system, which is equipped with coincidence
circuitry to allow the detection of  coincident 511 keV photon events.  The device can be
operated in either single photon or coincident photon mode.
B.  Device Description
1.  Description of the non-coincidence part of SPECT system
Describe as a conventional SPECT system.  Follow the guidelines described under Section
A of the document titled Single Photon Emission Computed Tomography (SPECT).
2.  Description of the coincident part of the SPECT system
Describe each component associated with coincidence detection.  Describe the design
principles of the devices coincidence detecting capability and discuss all the modifications,
from the original SPECT system, built into the system to improve the functionality of
coincidence imaging.
a.  Detector  system ---- Descriptions should include the type, size, and
thickness of the scintillator; and the number and size of PMTs; the
Constant Fraction Discriminator (CFD), scatter shields, axial filters,
coincidence detection circuitry, and the timing device.
b.  Performance specification of coincidence device ----  Provide the common
performance specifications including  spatial resolution (FWHM), system
sensitivity, energy resolution, count rate performance, coincidence window,
scatter fraction (%), count efficiency, coincidence dead time.
c.  Coincidence enhancement methods applied ----- Describe the methods used
to implement coincident imaging such as pulse shortening (pulse clipping),
multiple trigger channels, dual energy windows, shortening the dead time,
etc.
C.  Other Information
Other information to be submitted -- device photographs, diagrams and drawings, bench tests,
safety evaluation, hazard analysis, software, and clinical images -- are the same as for SPECT and
PET Imaging Systems respectfully.  Please follow the guidelines in Sections VIII, Single Photon
Emission Computed Tomography (SPECT) and IX, Positron Emission Tomography (PET) of this
guidance.
20 XI. Nuclear Tomography Systems
A.  Definition
A nuclear tomography system (NTS) is a device intended to detect nuclear radiation in the
body, using a scintillation (gamma) camera, and produce images of a specific cross-
sectional plane of the body by blurring or eliminating detail from the other planes by means
of synchronous motion of the camera collimator and the patient support assembly.
B.  Device Review Process
The device covered by this section used mechanical motion synchronized between the
camera collimator and patient table to create a tomographic effect with the image plane
parallel to the patient table.  Emission computed tomography superseded NTS as the
method of choice for performing nuclear medicine tomography. The last submission for
marketing approval for an NTS device was received in 1991.  CDRH, therefore, regards
NTS devices to be obsolete.  There are no submission guidances available for this type of
device.
21 Appendix 1
Declaration of Conformity
Voluntary Standards in 510ks
Reviewers should rely on a declaration of conformity to the recognized consensus standards if the
declaration
  identifies the applicable recognized consensus standards and specifies those that were
met;
  specifies, for each consensus standard, that all requirements were met, except for
inapplicable requirements or deviations noted below;
  identifies for each consensus standard any way(s) the standard may have been tailored
or modified for application to the device under review, e.g., identifies which of an
alternative series of tests were performed;
  identifies, for each consensus standard, any requirements that were not applicable to
the device;
  specifies any deviations from each applicable standard that were applied (e.g.,
deviations from international standards which are necessary to meet U.S. infrastructure
conventions such as the National Electrical Code (ANSI/NFPA 70));
  specifies what differences exist, if any, between the tested device and the device to be
marketed and justifies the use of test results in these areas of difference; and
  if a test laboratory or certification body was employed, provides the name and address
of each laboratory or certification body that was involved in the determining the
conformance of the device with the applicable consensus standards and a reference to
any accreditation of those organizations.
22 Appendix 2
510(k) Summary/Statement Certification
Re: K______________
CHECK ONLY ONE:
1.  510(k) Summary.  Attached is a summary of safety and effectiveness information upon
which an equivalence determination could be based.
2.  510(k) Statement. I certify that, in my capacity as
                                                                                                                                    
of                                                                                                         (company),
I will make available all information included in this premarket notification on safety and
effectiveness within 30 days of request by any person if the device described in the
premarket notification submission is determined to be substantially equivalent.  The
information I agree to make available will be a duplicate of the premarket notification
submission, including any adverse safety and effectiveness information, but excluding all
patient identifiers, and trade secret and confidential commercial information, as defined in
21 CFR 20.61.
                                                                                                                                 
[ Signature*]
                                                                                                                                 
[Typed or Printed Name]
                                             
[Date]
* Must be signed by a responsible person of the firm required to submit the
premarket notification (e.g., not a consultant for the 510(k) submitter).
23 Appendix 3
Indications for Use Form
Page       of      
510(k) Number (if known):                               
Device Name:                                            
Indications For Use:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
                                                                        
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use        OR Over-The-Counter Use      
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
24 Appendix 4
PREMARKET NOTIFICATION TRUTHFUL AND ACCURATE STATEMENT
(as required by 21 CFR 807.87(j))
I certify that, in my capacity as                                                                                                           
of                                                                     (company name), I believe, to the best of my
knowledge, that all data and information submitted in this premarket notification is truthful and
accurate and that no material fact has been omitted.
                                                                                                 
    (Signature*)     (Date)
                                                                                                 
(Typed Name) (510(k) number)
* Must be signed by a responsible person of the firm required to submit the premarket
notification (e.g., not a consultant for the 510(k) submitter).
25