Source: https://www.law.cornell.edu/cfr/text/21/884.2980?qt-cfr_tabs=1
Timestamp: 2016-02-14 01:49:52
Document Index: 204090128

Matched Legal Cases: ['art 884', '§ 884', '§ 884', '§ 884', '§ 351', '§ 360', '§ 360', '§ 360', '§ 360', '§ 371']

CFR › Title 21 › Chapter I › Subchapter H › Part 884 › Subpart C › Section 884.2980 21 CFR 884.2980 - Telethermographic system.
§ 884.2980
Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses—
Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses—
A telethermographic system for use as the sole diagnostic screening tool for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.
Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses - (1)
Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses - (1)
Identification. A telethermographic system for use as the sole diagnostic screening tool for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.
[53 FR 1566, Jan. 20, 1988, as amended at 55 FR 48440, Nov. 20, 1990; 66 FR 46953, Sept. 10, 2001] This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.United States CodeU.S. Code: Title 21 - FOOD AND DRUGS§ 351 - Adulterated drugs and devices§ 360 - Registration of producers of drugs or devices§ 360c - Classification of devices intended for human use§ 360e - Premarket approval§ 360j - General provisions respecting control of devices intended for human use§ 371 - Regulations and hearings