CLA-2 CO:R:C:G 087901 CMS
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.
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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-
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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
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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
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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,
John Durant, Director
Commercial Rulings Division