OT:RR:CTF:EMAIN H345915 MFT/TPB
Steven B. Zisser
Zisser Customs Law Group
9355 Airway Rd., Suite 1
San Diego, CA 92154
Re: Revocation of New York Ruling Letter (NY) N319324; Classification of Transducer
Arrays
Dear Mr. Zisser:
This is our decision in response to your request of February 26, 2025, filed on behalf of
your client Amphenol Critical Medical Technologies, LLC (formerly Providien Device
Assembly, LLC), for the revocation of New York Ruling Letter (NY) N319324, issued on May
25, 2021. There, U.S. Customs and Border Protection (CBP) classified certain transducer arrays
from Israel under heading 8543 of the Harmonized Tariff Schedule of the United States
(HTSUS). You request that CBP reclassify the merchandise at issue under heading 9018,
HTSUS. We reviewed NY N319324 and determined that it was in error and proposed revocation
of said ruling.
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. No. 103-182, 107 Stat. 2057, 2186 (1993), notice of the
proposed action was published on January 21, 2026, in Volume 60, Number 3, of the Customs
Bulletin. No comments were received in response to this notice. Accordingly, and for the reasons
set forth below, CBP is revoking NY N319324.
FACTS:
The subject merchandise consists of certain transducer arrays that are used with the
“Novocure” portable therapy delivery system to treat certain types of cancer. In your request,
you note that there are two models of the therapy delivery system – the “Optune Gio” and the
“Optune Lua” – and each model primarily consists of two components: (1) a separately-
presented electric field generator (i.e., a battery) and (2) the transducer arrays subject to this
decision.
Both the Optune Gio and Optune Lua are wearable, portable devices that generate tumor
treating fields (“TTFields”). TTFields are mild, alternating electric fields delivered through
adhesive patches (i.e., the transducer arrays), which are placed on the patient’s skin where a
tumor is located. 1 The TTFields disrupt the division of cancer cells by attracting and repelling
charged proteins during mitosis, thereby inhibiting tumor growth while minimally affecting
normal, healthy cells. 2 The Optune Gio is designed to treat glioblastoma multiforme (GBM), an
aggressive and common form of brain tumor. 3 The Gio’s transducer arrays are placed on the
patient’s shaved scalp. The Optune Lua, on the other hand, targets metastatic non-small cell lung
cancer (mNSCLC); its transducer arrays are placed on the front or back of the patient’s chest.
The transducer arrays for both the Gio and Lua connect directly to the electric field generator and
are made up of hydrogel, “minipads,” ceramic disks, flexible circuit boards, and medical tape.
NY N319324 adds “that the transducers do not electrically stimulate nerves or muscles,
nor do they heat tissue.” The ruling further notes your statement “that the system, within which
the transducer arrays are incorporated, is portable and allows the user to go about their day[-]to[-
]day lives while getting treatment for their disease.” NY N319324 classified the subject
merchandise under heading 8543, HTSUS, which provides for “Electrical machines and
apparatus, having individual functions, not specified or included elsewhere in this Chapter.”
We note that in your original request for NY N319324, you also sought guidance on the
subject merchandise’s eligibility for duty-free treatment under the secondary subheading
9817.00.96, HTSUS, which applies to articles and parts “specially designed or adapted for the
use or benefit of [. . .] physically or mentally handicapped persons.” While NY N319324
determined that the merchandise was eligible for duty-free treatment under that provision, CBP
later revoked this determination under Headquarters Ruling Letter (HQ) H330926, issued on
February 2, 2024, but did not address therein the primary classification of the transducer arrays
under heading 8543, HTSUS. We address that issue here.
ISSUE:
Whether the subject transducer arrays are classified under heading 8543, HTSUS, as
“[e]lectrical machines and apparatus, having individual functions, not specified or included
elsewhere” in Chapter 85, or under heading 9018, HTSUS, as instruments used in medical
sciences, including “other electro-medical apparatus.”
1
See generally Tumor Treating Fields (TTF) / Electrical Therapy, AM. CANCER SOC’Y,
https://www.cancer.org/content/dam/CRC/PDF/Public/9652.00.pdf (last visited July 3, 2025).
2
See id.; see generally Cornelia Wenger et al., A Review on Tumor-Treating Fields (TTFields): Clinical
Implications Inferred from Computational Modeling, 11 IEEE REV. BIOMED. ENG. 195–96 (2018).
3
See generally Glioblastoma Multiforme, AM. ASSOC. NEUROLOGICAL SURGEONS,
https://www.aans.org/patients/conditions-treatments/glioblastoma-multiforme/ (Apr. 15, 2024).
2
LAW AND ANALYSIS:
Classification under the HTSUS is in accordance with the General Rules of Interpretation
(GRIs). GRI 1 provides that the classification of goods will 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 2 through 6 will then be applied in order.
The Explanatory Notes (ENs) to the Harmonized Commodity Description and Coding
System represent the official interpretation of the tariff 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. 4
The HTSUS headings under consideration are as follows:
8543 Electrical machines and apparatus, having individual functions, not
specified or included elsewhere in this Chapter.
*****
9018 Instruments and appliances used in medical, surgical, dental or veterinary
sciences, including scintigraphic apparatus, other electro‑medical
apparatus and sight-testing instruments.
Section XVI of the HTSUS includes heading 8543, HTSUS. Note 1(m) to Section XVI
excludes “[a]rticles of Chapter 90,” which includes articles of heading 9018, HTSUS. If the
subject merchandise is classified under heading 9018, HTSUS, it is therefore excluded from
heading 8543, HTSUS. Thus, our inquiry begins by considering whether the transducer arrays
meet the terms of heading 9018, HTSUS.
The EN to heading 9018, HTSUS, states that the “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, dentists, veterinary surgeons, midwives), either to make a
diagnosis, to prevent or treat an illness or to operate, etc.” Additionally, “[t]he instruments and
appliances classified here [. . .] may also make use of electricity, either as motive power or for
transmission, or as a preventive, curative or diagnostic agent.”
We find it clear that the subject merchandise is classifiable under heading 9018, HTSUS.
First, the subject transducer arrays are “instruments or appliances,” as they are devices for
accomplishing a particular function – specifically, to apply TTFields where certain cancerous
cells are located. 5 Second, the facts indicate that the transducer arrays are “clearly identifiable”
as being for medical use. The plain and sole purpose of the merchandise is to work in tandem
with an electric field generator for the treatment of certain cancers. The devices are in fact used
“in professional practice [. . ] to prevent or treat an illness” inasmuch as the inhibition of tumor
4
See Treasury Decision (T.D.) 89-80, 54 Fed. Reg. 35127, 35127–28 (Aug. 23, 1989).
5
C.f. Trumpf Medical Systems v. United States, 34 C.I.T. 1404, 1415 (2010) (applying several dictionary
definitions that generally require that “[a]n appliance, device or machine” of heading 9018, HTSUS, accomplish
“one ‘simple task’ or serve a ‘particular function’ in providing ‘useful work’”).
3
cell division slows or stops its continued growth. As such, and third, the transducer arrays
patently “make use of electricity” as a “curative” agent, signifying their use as an “electro-
medical apparatus” described in the heading. Given these clear functions and characteristics, we
hold that the subject transducer arrays are instruments used in medical sciences, “including [. . .]
other electro-medical apparatus,” classifiable under heading 9018, HTSUS, and are thus
excluded from heading 8543, HTSUS.
HOLDING:
By application of GRIs 1 and 6, the subject transducer arrays are classified under
heading 9018, HTSUS, specifically subheading 9018.90.75, 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: Other instruments and appliances and parts and accessories thereof: Other:
Electro-medical instruments and appliances and parts and accessories thereof: Other: Other.” The
general column one rate of duty is free.
This ruling does not address the applicability of any additional duties that may apply to
the goods discussed herein. Likewise, 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 at www.usitc.gov.
EFFECT ON OTHER RULINGS:
NY N319324 (May 25, 2021) is hereby revoked.
In accordance with 19 U.S.C. § 1625(c), this ruling will become effective 60 days after
publication in the Customs Bulletin.
Sincerely,
Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division
4