CCD Camera Model 9000

• 2 recalls, same reason

  • Terminated Z-2147-2008 FDA Unclassified (pre-2012) ·initiated 1 Jul 2008 ·on shared 510(k) K990066
  • Terminated Z-2146-2008 FDA Unclassified (pre-2012) ·initiated 1 Jul 2008 ·on shared 510(k) K990066

  GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a specific angulated view associated with use of the Stereotactic Positioner of your Senographe DS Acquisition system and could impact patient safety. If the Stereotactic Positioner is removed when the examination arm is at 33 degrees and, th

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K990066 ↗

FDA Product Code

LMA

Device Class

Class II

Regulation

21 CFR Part 892.2030

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Diskcam Dc 6001

  Class I

  FDA 510(k) K884148 Active Cleared 23 Nov 1988

• Video Plus System, Series 95000

  Class II

  FDA 510(k) K992666 Active Cleared 13 Oct 1999

• Digital Imaging System

  Class II

  FDA 510(k) K954159 Active Cleared 19 Mar 1996

• Multicam I 8X10

  Class II

  FDA 510(k) K912341 Active Cleared 26 Aug 1991

• Color Diskstore

  Class II

  FDA 510(k) K922647 Active Cleared 11 Aug 1992

• Echocardiography System Series 95000

  Class II

  FDA 510(k) K992259 Active Cleared 8 Sep 1999

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• Is the CCD Camera Model 9000 designed for single-use or can it be reused in a clinical setting?

  The CCD Camera Model 9000 is explicitly described as a reusable Class II medical instrument. Since no sterility or single-use specifications are mentioned in the records, it is intended for repeated use in radiology environments after proper cleaning and maintenance.

• What types of radiological images can the CCD Camera Model 9000 digitize, and how does it improve diagnostic workflows?

  The CCD Camera Model 9000 is classified under product code LMA as a digitizer for radiological imaging, meaning it converts traditional radiographic images (such as X-rays) into digital format. By enhancing image clarity and accessibility, it streamlines diagnostic evaluation and reduces reliance on physical film, improving workflow efficiency in radiology settings.

• How was the FDA clearance for the CCD Camera Model 9000 determined, and what does ‘substantially equivalent’ mean in this context?

  The device received FDA 510(k) clearance in 1999 under the Radiology Advisory Committee, with a decision labeled as ‘Substantially Equivalent (SESE)’. This means the FDA determined that the CCD Camera Model 9000 has the same intended use and technological characteristics as a previously cleared ‘predicate’ device, ensuring it meets regulatory safety and effectiveness standards without requiring a full de novo review.

• Does the CCD Camera Model 9000 have any known compatibility or safety considerations for use in MRI environments?

  The provided records do not include any MRI safety data for the CCD Camera Model 9000. Clinicians should verify compatibility with their specific MRI systems and follow manufacturer guidelines to ensure safe use in mixed radiology environments.