CLA-2 CO:R:C:M 950433 MBR

District Director
U.S. Customs Service
555 Battery St., POB 2450
San Francisco, CA 94126

RE: Internal Advice 13/91; General Electric Nuclear Imaging Systems; Starcam 200; Starcam 3000; Instruments and Appliances Used in Medical, Surgical, Dental or Veterinary Sciences, Including Scintigraphic Apparatus

Dear Sir:

This is in reply to your memorandum dated February 7, 1991, forwarding Internal Advice request 13/91, submitted by counsel on behalf of the General Electric Company, regarding the classification of Nuclear Imaging Systems, under the Harmonized Tariff Schedule of the United States (HTSUS). Customs also considered submissions made by counsel directly to Headquarters.

FACTS:

The Nuclear Imaging System consists of a gamma camera mounted on a counterbalanced ring gantry, a data processing console with keyboard and display, and a patient table. To operate the system, the patient is injected with a radioactive tracer which is absorbed by the body tissues at varying levels. The level of emission of gamma rays from these tissues will vary according to the varying level of absorption. The gamma (or scintillation) camera is a radiation detection device which uses these variances in the levels of emission to create an image that provides medical diagnostic information.

ISSUE:

What is the classification of General Electric Nuclear Imaging System, under the Harmonized Tariff Schedule of the United States (HTSUS)? Is it classifiable in subheading 9018.19.80, HTSUS, which provides for instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other, or is classification more appropriate under subheading 9022.21.00, HTSUS, which provides for apparatus based on the use of

-2-

alpha, beta or gamma radiations, whether or not for medical, surgical, dental, or veterinary uses, as the importer argues?

LAW AND ANALYSIS:

The General Rules of Interpretation (GRI's) to the HTSUS govern the classification of goods in the tariff schedule. GRI 1 states, in pertinent part:

...classification shall be determined according to the terms of the headings and any relative section or chapter notes...

The Nuclear Imaging System consists of a gamma camera mounted on a counterbalanced ring gantry, a data processing console with keyboard and display, and a patient table.

The importer states: "[t]hese interrelated and interdependent components in the Nuclear Imaging System make it far more than a simple scintigraphic apparatus (see heading 9018), even though one item in the system meets that description, and clearly supports classification in Heading 9022."

However, the Harmonized Commodity Description and Coding System Explanatory Notes (ENs) to heading 9018 state:

(B) Special diagnostic instruments and apparatus.

These include:

(7) Diagnostic apparatus incorporating or operating in conjunction with an automatic data processing machine for processing and visualizing clinical data, etc.

(8) Apparatus incorporating a scintillation counter whose data are converted into analogue signals for the purpose of making medical diagnoses (e.g., gamma camera, scintillation scanner).

The importer argues that the instant merchandise does operate on the principles of "scintillation." However, the importer argues that it is not a "counter," but is an "imager" used for "radiography." However, Webster's New World Dictionary, Third College Edition (1984), defines "radiograph" as follows: "a picture produced on a sensitized film or plate by X-rays." However, the instant Nuclear Imaging System has no sensitized film or plate and does not operate by use of X-rays. Therefore, the instant merchandise could not be said to be based on radiography.

Furthermore, the ENs to heading 9022, HTSUS, page 1503, state:

-3-

This heading does not cover instruments and apparatus which are not designed to incorporate a radioactive source and which merely measure or detect radiation even when such instruments are calibrated in arbitrary terms. (Emphasis added).

Clearly, the Nuclear Imaging System does not incorporate a radioactive source, and is therefore not classifiable in heading 9022, HTSUS.

Counsel concedes that the Nuclear imaging system is prima facie classifiable in heading 9018, HTSUS, and heading 9022, HTSUS. He argues that heading 9022, HTSUS, is more specific than heading 9018, HTSUS. We disagree. Heading 9022, HTSUS, provides for: "[a]pparatus based on the use of X-rays or of alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary uses, including radiography or radiotherapy apparatus, X-ray tubes and other X-ray generators, high tension generators, control panels and desks, screens, examination or treatment tables, chairs and the like." This provision includes everything from apparatus for measuring the thickness of materials and monitoring the contents of packages, to fire alarms incorporating smoke detectors containing a radioactive substance. Clearly, a number of these articles are not for medical, surgical, dental or veterinary uses. Whereas, heading 9018, HTSUS, provides for: "[i]nstruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments." These are all ejusdem generis, applying only to apparatus used in the various medical disciplines, specifically including scintigraphic apparatus. Clearly, this is a more specific provision. Therefore, pursuant to GRI 3(a), the General Electric Nuclear Imaging System is classifiable in heading 9018, HTSUS.

Counsel demonstrated the existence of several different types of scintigraphic apparatus, attempting to exclude the instant merchandise from this class or kind of apparatus. However, it is Customs position that the instant merchandise is a technological advancement in this area, and as such, is not excluded from this provision, particularly since it operates on the same principles (scintigraphic) and performs the same functions (medical analysis) as the demonstrated models. See also Simmon Omega, Inc. v. United States, 83 Cust. Ct. 14, C.D. 4815 (1979), and Trans-Atlantic Co. v. United States, 471 F. 2d 1397, 60 CCPA 100, C.A.D. 1088 (1973), in which the courts have held that technological advancements and "improvement in the design of an article does not militate against its continuing to be a form of the named articles." Additionally, the courts have stated that "[i]t must also be remembered that the tariff statutes were enacted 'not only for the present but also for the future, thereby embracing articles produced by technologies which may not have been employed or known to commerce at the time of the enactment * * *.'" NEC America, Inc. v. United States, 8 CIT 184, 186 (1984), citing Corporacion Sublistatica, S.A. v. United

-4-

States, 1 CIT 120, 126, 511 F.Supp. 805, 809 (1981); See also Davis Turner & Co. v. United States, 45 CCPA 39, 41, C.A.D. 669 (1957).

The Medical Device Register (1987) which is the "Official Directory of Hospital Suppliers" (published by Directory Systems, Inc., of Stamford, Connecticut), defines a "Scintillation (gamma) camera" as follows:

A scintillation (gamma) camera is a device intended to be used to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories.

Therefore, it is the opinion of this office that the instant Nuclear Imaging System is, in fact, a "scintillation (gamma) camera." Furthermore, we consider a "scintillation (gamma) camera" to be a technological development of a "scintillation counter."

Counsel for the importer argues that: "[t]he nuclear imaging system is more than an 'instrument and appliance' and more than a scintigraphic detector because it also includes a digital computer which creates a visual image." We disagree. We refer counsel to chapter 90, Legal Note 3, which states: "[t]he provisions of note 4 to section XVI apply also to this chapter." Legal Note 4 to section XVI provides that:

Where a machine (including a combination of machines) consists of individual components (whether separate or interconnected by piping, by transmission devices, by electric cables or by other devices) intended to contribute together to a clearly defined function..., then the whole falls to be classified in the heading appropriate to that function.

Counsel also argues that under the Tariff Schedules of the United States (TSUS), the instant merchandise was classifiable under item 709.66, and that "[t]here are no significant changes in the language or the substance of Heading 9022, USHTS [sic], from item 709.66, both of which refer to apparatus employing gamma radiation." However, in fact there are significant changes between item 709.66, TSUS, and heading 9022, HTSUS. Item 709.66, TSUS, provides for "[a]pparatus based on the use of X-rays or of the radiations from radioactive substances, whether for medical, industrial, or other uses,...." Whereas, heading 9022, HTSUS, provides only for "[a]pparatus based on the use of X-rays or alpha, beta or gamma radiations...." Thus, heading 9022, HTSUS, does not provide for apparatus based solely on the use of radiations from radioactive substances, as item 709.66, TSUS, provided for.

-5-

Counsel additionally offers the U.S. International Trade Commission's table of comparative tariff provisions as proof of their argument. However, due to the change in tariff language, and the ENs clear exclusion of the instant merchandise from heading 9022, HTSUS, we do not find the USITC's general "Cross-Reference" binding on the instant classification.

Counsel inquires whether the provisions of subheading 9810.00.80, HTSUS, would apply to the instant merchandise, should it be found classifiable in heading 9018, HTSUS. Subheading 9810.00.80, HTSUS, provides for: "[a]rticles imported for the use of any nonprofit institution, whether public or private, established for educational, scientific or therapeutic purposes: [a]pparatus utilizing any radioactive substance in medical diagnosis or therapeutic treatment, including the radioactive material itself when contained in the apparatus as an integral element thereof, and parts or accessories of any of the foregoing."

It is Customs position that, while the instant merchandise does not "incorporate" any radioactive substances, it does "utilize" a radioactive substance since it produces an image by detecting radiation introduced into a patient, and would therefore fall within the purview of subheading 9810.00.80, HTSUS.

HOLDING:

The General Electric Nuclear Imaging System is classifiable in subheading 9018.19.80, HTSUS, which provides for: "[i]nstruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments: [e]lectro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters): [o]ther: [o]ther." Subheading 9810.00.80, HTSUS, may apply, contingent upon use.

The Internal Advice applicant should be advised of this decision.

Sincerely,

John Durant, Director
Commercial Rulings Division