9900 Plus Mobile Fluoroscopy System with 3D and Navigation Options

• • Terminated Z-1462-2014 FDA Class II ·initiated 31 Mar 2014

  GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and monitor to fall forward.

510(k) Number

K061953 ↗

FDA Product Code

OWB

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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