Model Dfp-8000D/Fpd Digital Radiography System with Flat Panel Detector

• • Terminated Z-0994-2013 FDA Class II ·initiated 8 Nov 2012 ·on shared 510(k) K052884

  Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed.

• • Terminated Z-0293-2008 FDA Unclassified (pre-2012) ·initiated 1 Oct 2007 ·on shared 510(k) K052884

  System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.

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

510(k) Number

K052884 ↗

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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• Ssa-390A/Power Vision 8000

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