CLA-2 RR:TC:GC 961394 gah
Port Director
U.S. Customs Service
JFK Airport, Building 77
Jamaica, New York 11430
RE: Protest 1001-97-106092; specular microscope
Dear Port Director:
This is a decision on protest 1001-97-106092 timely filed by counsel, on behalf of Topcon America Corporation, on September 25, 1997, against your decision regarding the classification of a specular microscope. All entries were liquidated on June 27, 1997. Descriptive marketing literature was submitted to this office for examination. A meeting was held with counsel on January 12, 1999. Other submissions were made on February 10, 1999, and April 26, 1999.
FACTS:
The merchandise is a specular microscope, style SP-2000P, produced by Topcon Corporation in Japan. It is specular in that it reflects light directly. It is electrically powered. It is optical, using a light source for observation and photography. It is a simple, or single stage microscope because it uses only an objective lens for magnification. There are no changeable optical elements. A charge coupler device camera turns the magnified image into digital data and displays the image on the monitor. That image can be increased into the desired size through computer technology, not magnification. The microscope is used by ophthamalogists and optometrists to examine and document the condition of the corneal endothelium, the rear most layer of the cornea.
The merchandise at issue 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), and is examined for the presence of deterioration. The merchandise at issue is not capable of surgery.
The protestant has withdrawn its protest as to other articles included within the entry at issue, namely seven pieces of “wall mount brackets for auto chart projectors” and 25 “metal parts for IMAGEnet.”
Customs classified the subject merchandise at entry in subheading 9018.50.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for other ophthalmic instruments and appliances. In the opinion of the Protestant that classification determination is incorrect. The Protestant advocates classification of the subject merchandise in subheading 9018.19.9550, HTSUS, which provides for other electro-diagnostic apparatus.
ISSUE:
Is the merchandise more specifically classified as electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters), and therefore classifiable in subheading 9018.19, or other ophthalmic instruments and appliances, and therefore classifiable in subheading 9018.50? If they are electro-diagnostic apparatus, are they 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 1 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 1 is to be classified in accordance with subsequent GRI.
Heading 9018 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 an objective lens, but no eyepiece with a separate lens. A charge couple device camera replaces the eyepiece. The microscope is therefore classifiable within this heading because it is not a compound optical microscope, and therefore does not meet the terms of heading 9011.
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 Dorland’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 specular microscope, style SP-2000P, 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.
The protest should be ALLOWED. In accordance with Section
3(A)(11)(b) of Customs Directive 099 3550 065, dated August 4, 1993, Subject: Revised Protest Directive, you are to mail this decision, together with the Customs Form 19, to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to mailing the decision.
Sixty days from the date of the decision, the Office of Regulations and Rulings
will make the decision available to Customs personnel, and to the public on the Customs Home Page on the World Wide Web at www.customs.gov, by means of the Freedom of Information Act, and other methods of public distribution.
Sincerely,
John Durant, Director
Commercial Rulings Division