Ceiling Mounted Radiographic System Traumex

• • Terminated Z-0787-05 FDA Unclassified (pre-2012) ·initiated 30 Sep 2004

  Some VersaRad Systems have a faulty weld that may result in oil leakage.

• • Terminated Z-0974-04 FDA Unclassified (pre-2012) ·initiated 23 Apr 2004

  If two of the four T-nuts that connect the transverse rail to the ceiling rail fail, the 'U' arm and transverse rails could fall and cause serious injury.

510(k) Number

K880530 ↗

FDA Product Code

IYB

Device Class

Class I

Regulation

21 CFR Part 892.1770

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Radiographic Floor Mounted Tubestand Fm 60

  Class I

  FDA 510(k) K893652 Active Cleared 23 Jun 1989

• Rms 180

  Class II

  FDA 510(k) K893673 Active Cleared 20 Jul 1989

• Elite R 90/15

  Class II

  FDA 510(k) K912741 Active Cleared 4 Oct 1991

• Fvp-1000 Family and Fvp-1000D Family

  Class II

  FDA 510(k) K905694 Active Cleared 27 Nov 1991

• Mammopath

  Class II

  FDA 510(k) K021113 Active Cleared 13 Jun 2002

• Imager

  Class II

  FDA 510(k) K883831 Active Cleared 21 Nov 1988

See all devices from Fischer Imaging Corp. →