Series 9600 Mobile Digital Imaging System

• • Terminated Z-1709-2008 FDA Unclassified (pre-2012) ·initiated 2 Jul 2008 ·on shared 510(k) K963952

  Secondary collimator filters may be missing on certain x-ray units. It was discovered that the secondary collimator filter on some OEC 9600 C-arms was omitted when a collimator assembly was replaced. This would reduce the filtration and therefore the Half-Value-Layer (HVL) of the X-ray beam, and may result in non-compliance with respect to Maximum Entrance Exposure Rate (EER) unless the maximum EE

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

510(k) Number

K963952 ↗

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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