DIGITAL ADD-ON BUCKY

K970136 · Swissray Teleray AG · KPR · Nov 21, 1997 · Radiology

Device Facts

• Record ID: K970136
• Device Name: DIGITAL ADD-ON BUCKY
• Applicant: Swissray Teleray AG
• Product Code: KPR · Radiology
• Decision Date: Nov 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Swissray Telleray AG Digital Add-on Bucky system is a high resolution, digital imaging system designed for Digital Photofluorography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general Radiography and fluoroscopy procedures are performed. The Digital Add-on Bucky is intended for applying general radiography on a patient in a supine, seated, or standing position including tomography examinations. The Digital Add-on Bucky system allows the operator to view and enhance the images. 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 Bucky system enables the operator to hardcopy images with a laser printer. The major system components include: a CCD camera, monitors and an image processor.

Device Story

Digital imaging system for photofluorography; replaces conventional film in general radiography and fluoroscopy. Inputs: X-ray signals captured via CCD camera. Processing: Image processor enables viewing and enhancement of diagnostic details. Outputs: Digital images displayed on monitors; hardcopy output via laser printer. Used in clinical settings by radiology staff. Benefits: Enhanced visualization of diagnostic details compared to conventional film; digital workflow integration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital imaging system; CCD camera sensor; image processor; display monitors; laser printer interface. Operates as an add-on to existing radiography/fluoroscopy equipment. Digital image acquisition and processing.

Indications for Use

Indicated for general radiography and fluoroscopy procedures, including tomography, in patients in supine, seated, or standing positions. Replaces conventional film techniques.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

NOV 21 1997

Michael Baker
CEO
Swissary Information Solutions
5775 Soundview Drive, Suite 103A
Gig Harbor, Washington 98335

Re: K970136
Swissary Telleray AG Digital Add-on Bucky System
Dated: November 4, 1997
Received: November 5, 1997
Regulatory class: II
21 CFR 892.1680/Procode: 90 KPR

Dear Mr. Baker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (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 the Electronic Product 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 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" (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,


Enclosure

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Page 1 of 1

510(k) Number (if known): _________________________

Device Name: Patriot

## Indication For Use:

The Swissray Telleray AG Digital Add-on Bucky system is a high resolution, digital imaging system designed for Digital Photofluorography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general Radiography and fluoroscopy procedures are performed. The Digital Add-on Bucky is intended for applying general radiography on a patient in a supine, seated, or standing position including tomography examinations.

The Digital Add-on Bucky system allows the operator to view and enhance the images. 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 Bucky system enables the operator to hardcopy images with a laser printer. The major system components include: a 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 Counter Use _________
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

David H. Nyerson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number R970136