Orbitor II Counter Balance Camera

• • Terminated Z-0617-03 FDA Unclassified (pre-2012) ·initiated 10 Feb 2003

  Unintended yoke rotational motion.

510(k) Number

K850397 ↗

FDA Product Code

IYX

Device Class

Class I

Regulation

21 CFR Part 892.1100

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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