Theratron 780E

• • Terminated Z-1179-06 FDA Unclassified (pre-2012) ·initiated 8 Jul 2004

  The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions.

510(k) Number

K964606 ↗

FDA Product Code

IWB

Device Class

Class II

Regulation

21 CFR Part 892.5750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• Theraplan Plus Version 1.2

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  FDA 510(k) K970236 Active Cleared 9 Jul 1997

• Theraplan Plus

  Class II

  FDA 510(k) K954679 Active Cleared 8 Nov 1996

See all devices from Theratronics, Inc. →