Clinac (R) C Series (400C, 600C, 2100C, 2500C)

• • Terminated Z-1074-2007 FDA Unclassified (pre-2012) ·initiated 2 May 2007

  The wedge tray may slip out of the Clinac interface mount during gantry rotation.

• • Terminated Z-1206-06 FDA Unclassified (pre-2012) ·initiated 6 Jun 2006

  Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.

• • Terminated Z-0777-05 FDA Unclassified (pre-2012) ·initiated 4 Feb 2005

  Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.

510(k) Number

K862645 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K844620 Active Cleared 1 Jul 1985

• Flouroscope, Mobile C-Arm Image Intens.

  Class II

  FDA 510(k) K760429 Active Cleared 23 Aug 1976

• Spectrophotometer Analysis Sys.

  Class I

  FDA 510(k) K771807 Active Cleared 28 Nov 1977

• Applicators for Varian Varisource Remote High Dose Rate Afterloader

  Class II

  FDA 510(k) K955844 Active Cleared 26 Jul 1996

• Spectrophotometer Analysis Sys., Aa-175

  Class I

  FDA 510(k) K770443 Active Cleared 8 Apr 1977

• Electron Beam Option for Clinac 15 Mev

  Class II

  FDA 510(k) K832502 Active Cleared 12 Sep 1983

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