CLA-2 OT:RR:CTF:EMAIN H311645 PF

Scott Cassell
JAS Forwarding USA, Inc.
1000 Centre Green Way, Suite 200
Cary, NC 27513

RE: Revocation of NY N300518; Classification of a fluorescence confocal microscope

Dear Mr. Cassell:

This is in reference to New York Ruling Letter (NY) N300518, dated October 10, 2018, issued to you on behalf of your client Mauna Kea Technologies, Inc., concerning the tariff classification of a fluorescence confocal microscope, under the Harmonized Tariff Schedule of the United States (HTSUS). We have reviewed NY N300518 and find it to be in error. For the reasons set forth below, we hereby revoke NY N300518.

Pursuant to section 625(c)(1), Tariff Act of 1930 (19 U.S.C. §1625(c)(1)), as amended by section 623 of Title VI (Customs Modernization) of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057), a notice of the proposed action was published in the Customs Bulletin, Vol. 56, No. 20, on May 25, 2022. No comments were received in response to this notice.

FACTS:

In NY N300518, CBP described the merchandise as follows: The product at issue, identified as the Cellvizio NOVA, is described as a standalone fluorescence confocal microscope. Per the information provided, the Cellvizio NOVA utilizes a confocal laser system with fiber optic probes that allow for the imaging of the internal microstructure of tissue. The instrument consists of a wheeled platform that incorporates the requisite laser imaging system, a touchable user interface (TUI), connectors for the fiber optic probes, and other peripheral equipment, such as a thermic printer. The Cellvizio NOVA is said to be suitable for use in a variety of applications, including gastroscopy, colonoscopy, bronchoscopy, and uteroscopy, among others. The Cellvizio NOVA utilizes its confocal laser system to generate endomicroscopic images that a physician can view (via the TUI) and print.

In addition, your ruling request stated that the Cellvizio NOVA was used by physicians in the clinical practice to obtain endomicroscopic images.

In NY N300518, U.S. Customs and Border Protection (CBP) classified the subject product under heading 9012, HTSUS, which provides for “Microscopes other than optical microscopes; diffraction apparatus; parts and accessories thereof.”

ISSUE:

Whether the fluorescence confocal microscope is classifiable in heading 9012, HTSUS, as microscopes other than optical microscopes, or in heading 9018, HTSUS, as instruments and appliances used in medical, surgical, dental or veterinary sciences.

LAW AND ANALYSIS:

Classification under the Harmonized Tariff Schedule of the United States (HTSUS) is made in accordance with the General Rules of Interpretation (GRI). GRI 1 provides that the classification of goods shall be determined according to the terms of the headings of the tariff schedule and any relative Section or Chapter Notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs may then be applied.

The HTSUS provisions under consideration are as follows:

9012 Microscopes other than optical microscopes; diffraction apparatus; parts and accessories thereof: 9012.10.00 Microscopes other than optical microscopes; diffraction apparatus * * * 9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters); parts and accessories thereof: 9018.19 Other: 9018.19.40 Apparatus for functional exploratory examination, and parts and accessories thereof.

The Harmonized Commodity Description and Coding System (HS) Explanatory Notes (ENs) constitute the official interpretation of the HS. While not legally binding or dispositive, the ENs provide a commentary on the scope of each heading of the HS at the international level, and are generally indicative of the proper interpretation of these headings. See T.D. 89-80, 54 Fed. Reg. 35127 (Aug. 23, 1989).

In NY N300518, the merchandise at issue was a fluorescence confocal microscope, also known as a probe-based Confocal Laser Endomicroscopy system. The instant Cellvizio NOVA used a confocal laser system with fiber optic probes that allowed for the internal imaging of the internal microstructure of tissue. Accordingly, the Cellvizio NOVA is prima facie classifiable in heading 9012, HTSUS, as a microscope. However, the Cellvizio NOVA is designed to enter the body of a person or an animal for purposes of examining and obtaining endomicroscopic images and is suitable for use in a variety of applications, including gastroscopy, colonoscopy, bronchoscopy, and uteroscopy, among others. Therefore, it is also prima facie classifiable in heading 9018, as an instrument and appliance used in medical, surgical, dental or veterinary sciences.

According to GRI 3(a):

When, by application of rule 2(b) or for any other reason, goods are, prima facie, classifiable under two or more headings, classification shall be effected as follows:

The heading which provides the most specific description shall be preferred to headings providing a more general description.…

Where articles can be classified under two HTSUS headings, under GRI 3(a) the classification "turns on which of these two provisions are more specific." Orlando Food Corp. v. United States, 140 F.3d 1437, 1441 (Fed. Cir. 1998). To do so, CBP will "look to the provision with requirements that are more difficult to satisfy and that describe the article with the greatest degree of accuracy and certainty." Orlando Food, 140 F.3d at 1441 (internal citations omitted). Under a GRI 3(a) analysis, heading 9018, HTSUS, prevails over heading 9012, HTSUS. The tariff terms “[i]nstruments and appliances used in medical, surgical, dental or veterinary sciences” heading are more specific than the tariff term “microscopes.” Accordingly, heading 9018, HTSUS is the most difficult provision to satisfy as it covers a narrower set of items than heading 9012, HTSUS. By application of GRI 3(a), we find that the Cellvizio NOVA is classified under heading 9018, HTSUS.

CBP has classified similar products in heading 9018, HTSUS. See NY N287815, dated July 21, 2017 (Cellvizio 100 Series – probe-based laser endomicroscopy system); NY N287804, dated July 19, 2017 (probe-based confocal laser endomicroscope designed for in-vivo imaging of small animals); NY N238114, dated March 5, 2013 (Cellvizio probe-based Confocal Laser Endomicroscope designed for in-vivo imaging of small animals); and N052415, dated March 13, 2009 (Cellvizio/Leica systems using Confocal Endomicroscopy and/or Fluorescence Optical Imaging). Since the Cellvizio NOVA is an endomicroscopy system that is designed to be used by physicians in clinical practice during gastroscopy, colonoscopy, bronchoscopy, and uteroscopy procedures, among others, it is also properly classified in heading 9018, HTSUS, which provides for “[i]nstruments and appliances used in medical, surgical, dental or veterinary sciences.”

HOLDING:

By application of GRI 1 and GRI 3(a), we find the subject fluorescence confocal microscope is classified heading 9018, HTSUS. By application of GRI 6, it is specifically provided for under subheading 9018.19.40, HTSUS, which provides for “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters); parts and accessories thereof: Other: Apparatus for functional exploratory examination, and parts and accessories thereof.” The column one, general rate of duty is free.

Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 9018.19.4000, HTSUS Annotated, unless specifically excluded, are subject to an additional 25 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.01, in addition to subheading 9018.19.4000, HTSUS Annotated, listed above. The HTSUS is subject to periodic amendment so you should exercise reasonable care in monitoring the status of goods covered by the Note cited above and the applicable Chapter 99 subheading. For background information regarding the trade remedy initiated pursuant to Section 301 of the Trade Act of 1974, you may refer to the relevant parts of the USTR and CBP websites, which are available at https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions and https://www.cbp.gov/trade/remedies/301-certain-products-china, respectively.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at https://hts.usitc.gov/current.

EFFECT ON OTHER RULINGS:

NY N300518, dated October 10, 2018, is hereby REVOKED.

In accordance with 19 U.S.C. 1625(c), this ruling will become effective 60 days after its publication in the Customs Bulletin.

Sincerely,

Craig T. Clark, Director
Commercial and Trade Facilitation Division