HQ 962596

April 13, 1999

CLA-2 RR:CR:GC 962596 gah

**CATEGORY: Classification**

**TARIFF NO.: 9018.19.9550**

Bio Optics, Inc.

1525 NE 41st Avenue

Portland, Oregon 97232

**RE:** Revocation of classification principle set forth in HQ 958579;
specular microscope, heading 9018.

Dear Sir or Madam:

This is in regard to HQ ruling (HQ) 958579 that was issued to you on
February 13, 1996, which decided protest 0401-95-100544 at the port of
Boston and addressed the tariff classification of a specular microscope
under the Harmonized Tariff Schedule of the United States Annotated
(HTSUSA). We have reviewed this ruling in light of a matter currently
before us on identical merchandise and have determined that HQ 958579 is
incorrect. Therefore, this ruling revokes HQ 958579 and sets forth the
correct classification for the specular microscope. This action has no
effect upon the decision in protest 0401-95-100544.

Pursuant to section 625(c), Tariff Act of 1930 (19 U.S.C. 1625(c),
notice of the proposed revocation of HQ 962596 was published on March
10, 1999, in the [Customs Bulletin]{.underline}, Volume 33, Number 10.
No comments were received in response to the notice.

**FACTS:**

The merchandise is Konan Medical\'s Noncon ROBO specular microscope
produced in Japan. It has a single stage of optics and is designed for
eye examination and photography. It has an adjustable chin rest for the
patient and a viewing screen for the doctor. The microscope has a
computerized system for analytical computations, and a photographic
capability for imaging a patient\'s corneal endothelium. The microscope
enables a wide field photography and a contact scanning of the cone lens
on the cornea. After screening with the contact microscope, more precise
examination is possible.

More specifically, the merchandise is a non-contact endothelial
microscope which measures the corneal endothelium and corneal thickness
of a patient\'s eye. The microscope works by fixing a position on the
cornea, taking a picture (image) of the

section of interest and displaying the measurement on a built-in
monitor. The image can be magnified through manipulation of the mouse.
Corneal cells can be identified, marked on the monitor screen, and
analyzed. The cell information is displayed on the monitor, and provides
reference values for the status of the endothelium. The endothelium is a
layer of cells in the back of the cornea. 6 McGraw-Hill Encyclopedia of
Science and Technology 5842 (1992). This layer of cells is examined for
the presence of deterioration. The merchandise at issue is not used in
surgery.

Customs decided the protest by classifying the microscope in subheading
9018.50.00, Harmonized Tariff Schedule of the United States (HTSUS),
which provides for other ophthalmic instruments and appliances, and
parts and accessories thereof.

**ISSUE:**

Is the merchandise properly classified as electro-diagnostic apparatus
(including apparatus for functional exploratory examination or for
checking physiological parameters), in subheading 9018.19, HTSUS, or
other ophthalmic instruments and appliances, in subheading 9018.50,
HTSUS? If the microscope is electro-diagnostic apparatus, is it for
functional exploratory examination?

**LAW AND ANALYSIS:**

Classification of merchandise under the Harmonized Tariff Schedule of
the United States Annotated (HTSUSA) is in accordance with the General
Rules of Interpretation (GRI). GRI I provides that classification shall
be determined according to the rules of the headings and any relative
section or chapter notes, taken in order. Merchandise that cannot be
classified in accordance with GRI I is to be classified in accordance
with subsequent GRI.

Heading 9018, HTSUS, provides for instruments and appliances used in
medical, surgical, dental or veterinary sciences, including
scintigraphic apparatus, other electro-medical apparatus and
sight-testing instruments. The microscope is used in medical, surgical,
dental or veterinary sciences. It has a single objective lens, and thus
provides one stage of magnification. The microscope is therefore
classifiable within this heading. It is not a compound optical
microscope, and therefore does not meet the terms of heading 9011,
HTSUS.

GRI 6 states, in summary, that classification at the subheading level is
determined according to the terms of the subheadings, on the
understanding that only subheadings at the same level are comparable,
The applicable competing subheadings within heading 9018 are:

> Electro-diagnostic apparatus (including apparatus for functional
> exploratory examination or for checking physiological parameters)

and

Other ophthalmic instruments and appliances

A diagnosis is the identification of a disease by careful investigation
of its symptoms and history. 1 Compact Edition of the Oxford English
Dictionary 714 (1987). The microscope is designed for eye examination,
scanning and photography. It is used in the visual investigation and
measurement of the physical structure of the endothelial cells of the
cornea to diagnose corneal edema (swelling) or other disease or trauma.
It therefore is accurately described as electro-diagnostic apparatus
(including apparatus for functional exploratory examination or for
checking physiological parameters), in subheading 9018.19, HTSUS.

The Harmonized Commodity Description and Coding System Explanatory Notes
(EN) constitute the official interpretation of the Harmonized System at
the international level. While neither legally binding nor dispositive,
the ENs provide a commentary on the scope of each heading of the HTSUS
and are generally indicative of the proper interpretation of these
headings. See T.D. 89-80, 54 FR 35127, 35128 (August 23, 1989).

The Explanatory Notes (EN) for heading 9018 lists three categories of
ophthalmic instruments: surgical, diagnostic and orthoptic or sight
testing apparatus. This is an indication that the drafters of the EN
believed that diagnostic apparatus are an identifiable category of
ophthalmic instruments. Subheading 9018.50 describes *other* ophthalmic
instruments and appliances. Thus, *other* ophthalmic instruments and
apparatus in subheading 9018.50 can include only ophthalmic apparatus
which are other than those provided for at the same subheading level in
heading 9018, including an ophthalmic instrument or apparatus which is
an electro-diagnostic apparatus, within subheading 9018.11 through
9018.19.

Within subheading 9018.19, the competing provisions for consideration
are subheading 9018.19.40, apparatus for functional exploratory
examination and subheading 9018.19.95, other apparatus.

*Functional* in the medical sense means that which relates to the normal
physiological activity of an organ, but not the structure, or anatomy,
of that organ. *See Dor/and\'s Illustrated Medical Dictionary* 667
(1994). The instant specular microscope permits the operator to observe
and record the structure of the eye, but not the activity going on in
the eye. It measures the parameters of endothelial cells. The goods do
not meet the definition of *functional.*

*Exploratory* in the medical sense means that which relates to an active
examination, usually involving endoscopy or a surgical procedure, to
ascertain conditions present as an aid in diagnosis. *Stedman\'s Medical
dictionary* 550 (1990). While the instant specular microscope certainly
aids in describing the condition of the eye, it does so through visual
examination from outside the body cavity, that is, without invasive
procedures. We do not believe the goods are *exploratory* in nature.

The specular microscope is specifically described as electro-diagnostic
apparatus for other than functional exploratory examinations.\'

**HOLDING:**

The Noncon ROBO specular microscope is properly classified in subheading
9018.19.9550, HTSUSA, as electro-diagnostic apparatus (including
apparatus for functional exploratory examination or for checking
physiological parameters); parts and accessories thereof, other, other,
other, other apparatus.

HQ 962596 dated February 13, 1996, is hereby revoked. In accordance with

19 U.S.C. 1625(c), this ruling will become affective 60 days after its
publication in the [Customs Bulletin]{.underline}.

Sincerely,

John Durant, Director

Commercial Rulings Division