CLA-2-90:RR:NC:N1:105 J88186
Mr. Richard Keen
Compliance Consultants
1151 Hope Street
Stamford, CT 06907
RE: The tariff classification of an ultrasound imaging device from Canada
Dear Mr. Keen:
In your letter dated June 2, 2003, received here August 22, 2003, you requested a tariff classification ruling. No sample was provided. You stated a brochure was attached with pertinent information, but none was found.
You described the import, which will sell for over $100,000 each, as follows:
“Description
Simply explained - this is an ultrasound scanning device used to visualize internal areas in mammals - so small, it is used as a microscope to research mice. The Vevo 660™ consists of a computer, an ultrasonic transmitter/receiver unit and a transducer that contacts the specimen. Instead of cutting a specimen (research mouse) the specimen is imaged using the Vevo 660™. This device will be labeled: Ultrasonic Research Device. Not for use on humans or animals for either diagnostic or therapeutic care. The device is used by “university” researchers. The device is NOT used by physicians (or medical technicians working under the supervision of a physician) to care for a human or an animal. The researcher typically uses information from the device (for example to discover - if a specimen is pregnant) for use in developing cancer disease models.
FDA Description
The Vevo 660™ is not controlled by the FDA except for the emission of
radiation such as Is a consumer television receiver. As required we have filed an abbreviated initial report for a NON-medical ultrasound Device. The FDA controls only HUMAN medical devices and as such this device does not require a marketing clearance such as a 510(k).
Typical Customer
The recipient (a scientific research laboratory) would not have a FDA registration Number. The recipient does not have an FDA registration number in regard to the use or dispensation of this device.”
As you indicate in your letter, the fact that your item will not be used in either diagnostic or therapeutic care for humans or animals is generally indicative that it should not be classified in HTS 9018. The Harmonized System Explanatory Notes to 90.18 state, “This 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…”
However, the EN does indicate that one exception is the apparatus used in autopsies, which are done for purposes not beneficial for the subject, but which are performed on the bodies of humans or animals and which routinely require knowledge and instruments that are very similar to those used in providing treatment or diagnosis to patients.
In your case, the import will be used living animals, one at a time, to produce images which presumably could be used in the diagnosis of that animal’s medical condition. Also, ultrasound is non-invasive so the risk to the animal would be relatively small as in veterinary ultrasound examinations.
Your device matches very closely the description of electro-diagnostic ultrasonic scanning apparatus in HS EN to 9018.12. Other than issues concerning regulatory approval, your item seems indistinguishable from a device which a veterinarian (or a technician working with the veterinarian) would use in examining any very small animal in the course of its treatment, including in determining whether it was pregnant.
We also note that the statutory language above HTS 9018.11-19 states that it includes, “apparatus for functional exploratory examinations or for checking physiological parameters.”
On that basis, we agree that the applicable subheading for your item will be 9018.12.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for certain Ultrasonic Scanning Apparatus. The rate of duty will be free.
Regarding the “emission of radiation,” it appears the requirements for a FDA form FD 2877 for Electronic Products per Customs Regulation 12.91-b will not apply. See 21 CFR (the Food and Drug Administration Regulations), Chapter 1, Subchapter J (Radiological Health), Part 1000 (General). More specifically, CBP requires the form only if the FDA has published Regulations establishing Performance Standards for that product, and, currently, for ultrasonic radiation-emitting products, only ultrasonic therapy products have a published Standard (in 21 CFR 1050.10.)
You state, “A class FD-1 is associated with the number 9018.12.0000,” and you ask what it is. “FD-1” indicates that CBP believes that FDA Notification 701 may be required (by you to the Food and Drug Administration.) It appears that you have already been in contact with them. However, if you wish to get more information regarding the FDA Notification 701, you should contact directly the U.S. Food and Drug Administration at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.
This ruling is being issued under the provisions of Part 177 of the Customs 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, contact National Import Specialist J. Sheridan at 646-733-3012.
Sincerely,
Robert B. Swierupski
Director,
National Commodity
Specialist Division