MEDICAL IMAGE DIGITIZER, MODEL 2908

K033637 · Array Corp. · LMA · Dec 17, 2003 · Radiology

Device Facts

• Record ID: K033637
• Device Name: MEDICAL IMAGE DIGITIZER, MODEL 2908
• Applicant: Array Corp.
• Product Code: LMA · Radiology
• Decision Date: Dec 17, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

Model 2908 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images, as the digital data, to a computer. This device has no patient contacting materials and is intended to be used by trained personnel only. The output of the device is to be evaluated by additionally trained personnel capable of sufficient review to afford identification and intervention In case of malfunction.

Device Story

Film Digitizer Model 2908 is an image scanner; inputs are black and white X-ray films; device uses transmitted light to read film images; transforms analog film images into digital data; transfers digital data to a computer; used in clinical settings by trained personnel; output is a digital image for review by trained personnel; enables digital storage, viewing, and analysis of X-ray images; facilitates clinical decision-making by providing digitized diagnostic images.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Medical image digitizer; optical scanner using transmitted light; transfers digital data to computer; no patient-contacting materials; standalone device.

Indications for Use

Indicated for use by trained personnel to scan black and white X-ray film images and transfer them as digital data to a computer for evaluation by trained personnel.

Regulatory Classification

Identification

A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 7 2003

Mr. Takashi Inami Manager Research & Development Dept. Array Corporation 3-42-10 Yoyogi, Shibuya-ku Tokyo, 151-0053 JAPAN

## Re: K033637

Trade/Device Name: Film Digitizer, Model 2908 Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: 90 LMA Dated: November 5, 2003 Received: November 19, 2003

Dear Mr. Inami:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. brigdon

Nancy C. Brogdor Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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KO33637 510(k) Number (If known): Not known

Device Name: Film Digitizer, Model 2908

Indications for Use:

Model 2908 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images, as the digital data, to a computer.

This device has no patient contacting materials and is intended to be used by trained personnel only.

The output of the device is to be evaluated by additionally trained personnel capable of sufficient review to afford identification and intervention In case of malfunction.

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Prescription Use √

OR Over The Counter Use

(Optional Format 1-2-96)

Hancy C Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033637