HQ 0087901 - Laitinen Stereotactic System; Frames Used In Medical Imaging To Localize Lesions And Targets; Percutaneous Tumor Biopsy Kit; Instruments And Appliances Used In Medical Or Surgical Sciences; Apparatus Based On The Use Use Of X-Rays Or Other Radiations - United States International Trade Commision Rulings

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HQ 087901

January 9, 1991

CLA-2 CO:R:C:G 087901 CMS

CATEGORY: CLASSIFICATION

TARIFF NO.: 9018.32.00
9018.39.00
9018.90.80
9022.90.20
9022.90.60

District Director of Customs
111 West Huron Street
Buffalo, NY 14202

RE: Laitinen Stereotactic System; Frames Used In Medical Imaging To Localize Lesions And Targets; Percutaneous Tumor Biopsy Kit; Instruments And Appliances Used In Medical Or Surgical Sciences; Apparatus Based On The Use Use Of X-Rays Or Other Radiations

Dear Sir:

This is in response to your Request for Internal Advice No. 35/90, dated April 20, 1990, regarding the classification of the Laitinen Stereotactic System.

FACTS:

The merchandise consists of medical equipment described by the importer as the Laitinen Stereotactic System. The system is used in the stereotactic imaging process in which the exact locations of targets within the body, such as brain tumors, can be determined. The system includes steel frames which are mounted to the patient's head. The frames act as mechanical reference structures and appear on the X-ray or other image of the patient's head. The imaging apparatus, which is not imported with the system under consideration, may utilize the technology of computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), angiography, ventriculography, radiography or fluoroscopy.

The Laitinen Stereotactic System consists of the Laitinen Stereoadapter 5000, Stereoadapter 5000 accessories, Percutaneous Tumor Biopsy Kit, Laitinen Stereoguide 2000 and Stereoguide 2000 accessories.

The Laitinen Stereoadapter 5000 is a framework made of armed plastic and duraluminum. The Stereoadapter is mounted on the patient's head by means of two ear plugs and a nasion support. Fluid filled plastic tubes or lead pin indicators may be attached to the framework to aid in its function depending on the imaging method used. The Stereoadapter will be commercially sold only to hospitals, clinics or physicians. The Stereoadapter is designed to provide accurate intracranial target localization for diagnostic or treatment planning purposes.

The Stereoadapter accessories are described on a price list attached to the ruling request. The accessories consist of articles which aid in the operation of the Stereoadapter, and include immobilization plates, plastic tubes filled with copper sulfate solution, and ear plugs.

The Percutaneous Tumor Biopsy Kit is also an accessory to the Stereoadapter but is described and packaged separately. The Kit is used to provide stereotactic guidance towards brain tissue, and for surgical biopsy of brain tumors without the need of an invasive, rigidly fixed stereotactic frame. The Kit consists of a phantom base which can be fixed inside the Stereoadapter, and a probe carrier with multijoint locking mechanism which is fixed to the connector plate of the Stereoadapter. Also included in the Kit are a twist bone drill, monopolar diathermis probe and a biopsy needle.

The Laitinen Stereoguide 2000 is similar to the Stereoguide in that it is a stereotactic frame with medical applications based on the spatial orientations of intracranial targets in relation to a reference structure. Unlike the Stereoadapter, the Stereoguide is rigidly fixed to the patient's skull. The Stereoguide was developed prior to the emergence of CT or MRI imaging technology and has been rendered superfluous in many applications due to the availability of non-invasive localizers such as the Stereoadapter. The Stereoguide is essentially an accessory to the Stereoadapter but may be used as the principal localizer in conjunction with X-ray fluoroscopy.

The Stereoguide accessories consist of articles which aid in the use of the Stereoguide with mobile X-ray machines, or aid in the use of the Stereoguide in directing epilepsy monitoring probes from a lateral trajectory. The accessories include floor stands, threaded bolts and screws, and drill guiding cannula.

ISSUE:

Is the merchandise classified as instruments and appliances used in medical or surgical science and parts and accessories thereof, in Heading 9018, or as apparatus based on the use of X-
rays or of other radiations and parts and accessories thereof, in Heading 9022?

LAW AND ANALYSIS:

Heading 9018 in pertinent part describes instruments and appliances used in medical or surgical sciences and parts and accessories thereof.

Heading 9022 in pertinent part describes apparatus based on the use of X-rays or of alpha, beta or gamma radiations, whether or not for medical or surgical uses, control panels and desks, screens, examination or treatment tables, chairs and the like, and parts and accessories thereof.

The ruling requestor argues that many of the articles under consideration should be classified as Heading 9022 accessories because Heading 9022 provides a more specific description of the merchandise than the more general Heading 9018. It is argued that the articles are integrally used with an imaging technique (e.g., CT, MRI, PET, angiography, fluoroscopy, ventriculography), and that the results of stereotactic imaging are reliant on the use of the articles.

The classification of merchandise under the HTSUSA is governed by the General Rules of Interpretation (GRI's). GRI 1 provides in pertinent part that for legal purposes, classification shall be determined according to the terms of the headings and the relative section or chapter notes.

Chapter 90 Note 2 is a relative chapter note. Chapter 90 Note 2(a) provides in pertinent part that parts and accessories which are goods included in any of the headings of Chapter 90 are in all cases to be classified in their respective headings. Thus, if the merchandise consists of goods of Heading 9018 (i.e., as instruments and appliances used in medical and surgical sciences), then they are classified in Heading 9018 and not as parts or accessories in Heading 9022 (see also Explanatory Notes to Chapter 90 Note 2, p. 1457).

The Explanatory Notes to Heading 9018, p. 1487, provide in part that "[t]his heading covers a very wide range of instruments and appliances which, in the vast majority of cases, are used only in professional practice (e.g., by doctors, surgeons...) either to make a diagnosis, to prevent or treat an illness or to operate, etc."

The Stereoadapter 5000, Percutaneous Tumor Biopsy Kit and Stereoguide 2000 are used by professional medical personnel such as physicians. The Stereoadapter 5000 is used to provide intracranial target localization for diagnostic or treatment
planning purposes. The Stereoadapter 2000 may be used in conjunction with the Stereoadapter, but may also be used like the Stereoadapter 5000 as the primary localizer. The Percutaneous Tumor Biopsy Kit is used to provide stereotactic guidance towards brain tissue, and for surgical removal after guidance is complete. Some of the components of the Percutaneous Tumor Biopsy Kit (e.g., biopsy needle and bone drill) are specifically described by the Explanatory Notes to Heading 9018 (needles, p. 1488; tools clearly identifiable for medical or surgical use, p. 1488).

The Stereoadapter 5000, Percutaneous Tumor Biopsy Kit and Stereoguide 2000 are described by Heading 9018 and are goods included in Heading 9018. Pursuant to Chapter 90 Note 2, the goods are classified in Heading 9018 and not as parts or accessories in Heading 9022.

The Stereoadapter 5000 is classified as an other instrument and appliance used in medical and surgical sciences, in 9018.90.80, HTSUSA.

The Stereoadapter 5000 accessories are classified as parts and accessories of other instruments and appliances used in medical and surgical sciences, in 9018.90.80, HTSUSA.

The biopsy needle component of the Percutaneous Tumor Biopsy Kit is specifically provided for as tubular metal needles in 9018.32.00, HTSUSA. The phantom base, probe carrier with multijoint locking mechanism, twist bone drill and monopolar diathermis probe are classified as parts and accessories in 9018.90.80, HTSUSA. The "Kit" cannot be classified as a GRI 3(b) set in part because all the components are classifiable in the same heading.

The Stereoguide 2000 is described as an other instrument and appliance used in medical and surgical sciences, classified in 9018.90.80, HTSUSA.

The Stereoguide accessories consisting of the threaded bolts and screws are Section XV Note 2 "[p]arts of general use", and are excluded from Chapter 90 by Chapter 90 Note 1(e). The threaded bolts and screws are classified in subheadings 7318.15.20 to 7318.15.80, depending on their lengths and shank thread diameters. The Stereoguide accessories consisting of the drill guiding cannula are provided for as cannulae in subheading 9018.39.00. The remaining accessories of the Stereoguide are classified as parts and accessories in 9018.90.80, HTSUSA.

Because the classification of the merchandise is determined by Chapter 90 Notes 1 and 2, which are GRI 1 legal notes, it is
neither necessary nor proper to resort to a GRI 3(a) analysis according to the heading which more specifically describes the merchandise.

The merchandise is also not classified as Heading 9022 apparatus. The merchandise is not described by the Explanatory Notes for Heading 9022 apparatus, and is not similar to the Explanatory Note exemplars for Heading 9022 apparatus, pp. 1500- 1501.

HOLDING:

The Stereoadapter 5000 is classified as an other instrument and appliance used in medical and surgical sciences, in 9018.90.80, HTSUSA.

The Stereoadapter 5000 accessories are classified as parts and accessories of other instruments and appliances used in medical and surgical sciences, in 9018.90.80, HTSUSA.

The biopsy needle component of the Percutaneous Tumor Biopsy Kit is classified as a tubular metal needle in 9018.32.00, HTSUSA. The phantom base, probe carrier with multijoint locking mechanism, twist bone drill and monopolar diathermis probe are classified as parts and accessories in 9018.90.80, HTSUSA.

The Stereoguide 2000 is classified as an other instrument and appliance used in medical and surgical sciences, in 9018.90.80, HTSUSA.

The Stereoguide accessories consisting of the threaded bolts and screws are classified in subheadings 7318.15.20 to 7318.15.80, depending on their lengths and shank thread diameters. The Stereoguide accessories consisting of drill guide cannula are classified in 9018.39.00, HTSUSA. The remaining accessories of the Stereoguide are classified as parts and accessories in 9018.90.80, HTSUSA.

Provided the requirements of the United States-Canada Free- Trade Agreement are met, the merchandise may be accorded the applicable reduced duty treatment pursuant to the Agreement. A copy of this decision should be provided to the internal advice applicant.

Sincerely,

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