DIGITAL ADD ON MULTI SYSTEM

K973710 · Swissray International, Inc. · KPR · Dec 18, 1997 · Radiology

Device Facts

• Record ID: K973710
• Device Name: DIGITAL ADD ON MULTI SYSTEM
• Applicant: Swissray International, Inc.
• Product Code: KPR · Radiology
• Decision Date: Dec 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Swissray Tellerav AG Digital Add-on multi system is a high resolution, digital X-Ray system designed for Digital Photofluorography. It is intended to replace conventional film techniques in multipuroose or dedicatedapplications where general Radiography procedures are performed. The AddOn multi System is intended for applying general radiography on a patient in a supine, seated, or standing position . The AddOn multi system allows the operator to view and enhance the images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. The Add-on multi system enables the operator to hardcopy images with a laser printer. The major system components include: an optional floating table, x-ray generator, x-ray tube, digital AddOn Bucky: CCD camera, monitors and an image processor.

Device Story

Digital X-ray system for general radiography; replaces conventional film. Inputs: X-ray radiation captured by CCD camera via digital AddOn Bucky. Components: X-ray generator, X-ray tube, optional floating table, image processor, monitors. Operation: Physician/technician positions patient (supine, seated, standing); system captures, processes, and displays images. Features: Image enhancement to improve diagnostic detail visibility; laser printer output for hardcopies. Benefit: Improved visualization of diagnostic details compared to conventional film.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Digital X-ray system; CCD camera-based image acquisition; includes X-ray generator, tube, image processor, and monitors. Supports image enhancement and laser printing. Stationary system.

Indications for Use

Indicated for general radiography procedures on patients in supine, seated, or standing positions, replacing conventional film techniques for digital photofluorography.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 18 1997

Michael Baker CEO Swissray International, Inc. 577 Soundview Drive, Suite 103A Gig Harbor, WA 98335

Re:

Digital Addon Multi System, Stationary X-Ray System Dated: September 14, 1997 Received: September 29, 1997 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR

Dear Mr. Baker:

We have reviewed your Section 510K) notification of intent to market the device and we have determined the device is substantially equivalent for the indications for use stated in interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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.

K973710

If your device is classified (see above) into either class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

W.Lliau Yin
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page I of I

51 0(k) Number (if known): K9737/0

Device Name:AddOn Multi System

Indication For Use:

The Swissray Tellerav AG Digital Add-on multi system is a high resolution, digital X-Ray system designed for Digital Photofluorography. It is intended to replace conventional film techniques in multipuroose or dedicatedapplications where general Radiography procedures are performed. The AddOn multi System is intended for applying general radiography on a patient in a supine, seated, or standing position .

The AddOn multi system allows the operator to view and enhance the images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques.

The Add-on multi system enables the operator to hardcopy images with a laser printer. The major system components include: an optional floating table, x-ray generator, x-ray tube, digital AddOn Bucky: CCD camera, monitors and an image processor.

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

.

Concurrence of CDRH, Office of Device Evaluation (DOE)

Prescription Use

or

Over-The CounterUse

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

=

Elmer C. Deymon

f Reproductive, Abdominal, F 510/k) Number