The eligibility of a mammography device under the Nairobi Protocol treatment from France

N353211
September 18, 2025
CLA-2-90:OT:RR:NC:N3:135
CATEGORY: Classification
TARIFF NO.: 9817.00.96
Matthew Robert Gunkel GE Precision Healthcare LLC 3000 N Grandview Blvd Waukesha, WI 53188 RE: The eligibility of a mammography device under the Nairobi Protocol treatment from France Dear Mr. Gunkel: In your letter dated September 3, 2025, you requested a tariff classification ruling. Pristina Via is a full digital mammography system designed to accommodate the needs of individuals in wheelchairs so they can roll their wheel chairs under the device. You state that a normal mammogram machine does not allow for that. The breast platform is the most critical component that needs to go low enough to allow the patient access to the machine to do the exam while seated. It was determined that the height should be 26 inches from the floor to the top of the breast platform. Additionally, there also needs to be enough knee and toe clearance to ensure that the patient can get close enough to the breast platform without knees or feet hitting parts of the equipment. The appropriate distance was determined to be a minimum of 28 inches to allow for chair and body to sit comfortably and properly during the exam. You state that the base must be low enough so that a patient’s footrests can ride over it and it must allow enough unobstructed floor space to ensure that a wheelchair’s front caster wheels do not hit it. You also state that the configuration of the positioning supports must provide enough flexibility for all patients to be able to reach and hold them, including those in a wheelchair, to make this accommodation the base support maximum height is 1.5 inches and provides rooms for the structural components. You state the typical mammography machine was intended for use by patients that can stand and position their bodies close to the machine. H ealthcare providers who provide mammogram services to both able-bodied and handicapped persons would be required to have two machines. You claim that the Pristina Via is primarily for the use of handicapped people and it is a device that is specially designed to adapt the mammography machine for use by a physically handicapped individual using a wheelchair. The features are not features that are necessary for the general public. It is unnecessary for a non-handicapped person to be seated while using the mammography machine. You state it is not more comfortable for a non-handicapped person to use this device and therefore easily distinguishable from articles useful to the general public. You confirm that GE Healthcare serves patients with disabilities and would be

considered a specialty company for this type of equipment. Marketing materials specifically highlight that the Pristina Via is intended for the use of individuals in wheelchairs. The importer would be very aware of this capability. In your submission you requested consideration of a classification under subheading 9817.00.96, Harmonized Tariff Schedule of the United States (HTSUS), which covers: “[a]rticles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons; parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles: [o]ther.” The term “blind or other physically or mentally handicapped persons” includes “any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS. Subheading 9817.00.96, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles, dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic articles; or, (iv) medicine or drugs.” You argue that although subheading 9817.00.96, HTSUS, excludes diagnostic articles, the Pristina Via is still classifiable under it. The basis for this classification is that the device diagnoses breast masses that may turn out to be breast cancer, a use distinct from diagnosing the underlying condition (such as arthritis or other muscular or skeletal deficiencies) causing an inability to walk. We disagree. Given that this is a diagnostic article and based on the plain text language of U.S. Note 4(b)(iii), subchapter XVII, Chapter 98, this office's opinion is that the Pristina Via is precluded from subheading 9817.00.96, HTSUS. The tariffs and additional duties cited above are current as of this ruling’s issuance. 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 https://hts.usitc.gov/. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Fei Chen at [email protected].
Sincerely,
(for)

Denise Faingar Acting Director National Commodity Specialist Division