CCD CAMERA, MODEL PKP-06000-000

K024085 · Perkins Electronics Co. · IZJ · Mar 11, 2003 · Radiology

Device Facts

• Record ID: K024085
• Device Name: CCD CAMERA, MODEL PKP-06000-000
• Applicant: Perkins Electronics Co.
• Product Code: IZJ · Radiology
• Decision Date: Mar 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1620
• Device Class: Class 2

Intended Use

This Device is a Charged Coupled Device (CCD) camera for use in digital radiography, including DSA, high-resolution cardiology, and low dose fluoroscopy. It is designed for use with X-Ray image intensifiers in diagnostic imaging chains. The purpose of this device is to convert the visible image at the output of the X-Ray system image intensifier, to a video signal for display on a TV monitor.

Device Story

Model PKP-06000 CCD camera; component of diagnostic imaging chains. Input: visible light image from X-Ray image intensifier output. Transformation: CCD sensor converts optical image to video signal. Output: video signal for display on TV monitor. Used in clinical diagnostic imaging environments; operated by trained medical imaging personnel. Facilitates visualization of X-ray images for diagnostic purposes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

CCD (Charged Coupled Device) camera; designed for integration with X-Ray image intensifiers; converts optical output to video signal for display; class II device under 21 CFR 892.1620.

Indications for Use

Indicated for use in digital radiography, including DSA, high-resolution cardiology, and low dose fluoroscopy, as a component of diagnostic imaging chains using X-Ray image intensifiers.

Regulatory Classification

Identification

A cine or spot fluorographic x-ray camera is a device intended to photograph diagnostic images produced by x-rays with an image intensifier.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 11 2003

Mr. Jim Furse Vice President, Engineering Perkins Electronics, Co. 1510 N. Washington Ave. DALLAS TX 75204

Re: K024085

Trade/Device Name: Model PKP-06000 CCD Camera Regulation Number: 21 CFR 892.1620 Regulation Name: Cine or spot fluorographic x-ray camera Regulatory Class: II

Product Code: 90 IZJ Dated: December 10, 2002 Received: December 11, 2002

Dear Mr. Furse:

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 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. Brogdon

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: PERKINS ELECTRONICS, Model PKP-06000 CCD Camera

Indications for Use:

This Device is a Charged Coupled Device (CCD) camera for use in digital radiography, including DSA, high-resolution cardiology, and low dose fluoroscopy. It is designed for use with X-Ray image intensifiers in diagnostic imaging chains. The purpose of this device is to convert the visible image at the output of the X-Ray system image intensifier, to a video signal for display on a TV monitor.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

4085

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)