CLA-2 RR:CR:GC 962596 gah
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, 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.
Sincerely,
John Durant, Director
Commercial Rulings Division