Theraton 1000E

• • Terminated Z-1181-06 FDA Unclassified (pre-2012) ·initiated 8 Jul 2004 ·via K964607, on the same 510(k)

  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.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K964607 ↗

FDA Product Code

IWD

Device Class

Class II

Regulation

21 CFR Part 892.5750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Theraplan V05B/ Tp-11 V09B

  Class II

  FDA 510(k) K940237 Active Cleared 26 Jul 1994

• Theratron 780E

  Class II

  FDA 510(k) K964606 Active Cleared 26 Jun 1997

• Theratron 1000

  Class II

  FDA 510(k) K894165 Active Cleared 1 Feb 1990

• Theratronic Stimulator

  Class II

  FDA 510(k) K820782 Active Cleared 3 Jun 1982

• Theraplan Plus Version 1.2

  Class II

  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. →