Compax (40 +2 more) - 400

• • Terminated Z-0457-2010 FDA Unclassified (pre-2012) ·initiated 30 Jul 2009

  GE Healthcare has recently become aware that table lock safety features, which are provided with Compax 40E X-ray systems, are not always being utilized and has resulted in unintended lateral tabletop movement that may impact patient safety.

510(k) Number

K884930 ↗

FDA Product Code

IZZ

Models / Variants

40

400

400T

Device Class

Class II

Regulation

21 CFR Part 892.1980

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Generator, High Volt, X-Ray, Diag. MPX80

  Class I

  FDA 510(k) K802548 Active Cleared 2 Dec 1980

• Senograph Ds, Senograph Essenstial

  Class II

  FDA 510(k) K103485 Active Cleared 6 Oct 2011

• Senographe Ds, Senographe Essential

  Class II

  FDA 510(k) K110798 Active Cleared 22 Dec 2011

• GE CT/T 8800 System

  Class II

  FDA 510(k) K780326 Active Cleared 14 Mar 1978

• CT Pace Catalog Number B7950A

  Class II

  FDA 510(k) K872526 Active Cleared 23 Sep 1987

• Series 620 Rectal Probe Cover

  Class II

  FDA 510(k) K864222 Active Cleared 4 Mar 1987

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