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NY N024596

April 10, 2008



TARIFF NO.: 9018.19.9550

Mr. Thomas F. Barnish
Imalux Corporation
11000 Cedar Avenue, Suite 250
Cleveland, OH 44106

RE: The tariff classification of a Niris Imaging System.

Dear Mr. Barnish:

In your letter dated March 4, 2008, you requested a tariff classification ruling. No sample was provided, but a data disk with 30 additional pages worth of information was submitted.

You state in your letter:

The Imalux system, trademarked as Niris Imaging System ™ employs Optical Coherence Tomography (OCT), which can be used to construct high spatial resolution [~10-20 micrometers], cross-sectional images of tissue microstructure. The principle of OCT is similar to B-mode ultrasound imaging, except that OCT uses near infrared light instead of sound. The principle of operation is very similar to ultrasound and radar in the sense that tissue layers at different depths are resolved based upon the wave propagation time from the emitter to the corresponding tissue layer and back to the receiver. Although OCT imaging is not as deep as with ultrasound, the resolution of OCT can be up to 100 times finer than standard clinical ultrasound. OCT provides structural, rather than chemical, information about the tissue, and can be used to image anatomical areas in stratified tissues and to visualize structural disruptions. Many diagnostically important tissue alterations occur within this depth, and conventional biopsy with histology typically achieves the same or lesser penetration. Imaging depth is limited by optical attenuation from tissue scattering and absorption, but can be increased by gently compressing the tissue.

As stated on the data disk:

Like many complementary imaging modalities, OCT imaging offers the physician additional clinical information to facilitate and aid in the physician’s diagnosis and treatment plan.

The device has a long, thin probe. While it can be used to analyze external areas of the patient, per you data disk, internal areas such as vaginal and vocal folds, the esophagus, etc, would be more typical.

The applicable subheading for the Niris Imaging system will be 9018.19.9550, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “other” Electro-diagnostic apparatus.

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.


Robert B. Swierupski

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