IWB · Class II · 21 CFR 892.5750

FDA Product Code IWB: System, Radiation Therapy, Radionuclide

Leading manufacturers include Elekta Instrument AB, Theratronics, Inc. and Akesis, Inc..

48
Total
48
Cleared
126d
Avg days
1978
Since
48 devices
25–48 of 48
Cleared Apr 06, 2006
ROTATING GAMMA SYSTEM. GAMMA ART-6000
K060314
American Radiosurgery, Inc.
Radiology · 57d
Cleared Mar 09, 2006
THERATRON EQUINOX, MODELS 80 CM AND 100 CM
K053485
Mds Nordion, Inc.
Radiology · 84d
Cleared Jun 01, 2005
GAMMAPLAN
K051022
Elekta Instrument AB
Radiology · 40d
Cleared Dec 30, 2004
MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)
K041125
Masep Med Science & Tech. Development (Shenzhen) C
Radiology · 244d
Cleared Apr 27, 2000
THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE
K001006
Mds Nordion
Radiology · 29d
Cleared Apr 19, 2000
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1
K000478
Accuray, Inc.
Radiology · 65d
Cleared Jul 14, 1999
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K984563
Accuray, Inc.
Radiology · 203d
Cleared May 21, 1999
LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
K984328
Elekta Instrument AB
Radiology · 169d
Cleared Dec 04, 1998
THERATRON ELITE
K983917
Theratronics, Inc.
Radiology · 30d
Cleared Apr 01, 1998
LEKSELL GAMMAPLAN
K973441
Patterson Consulting Group, Inc.
Radiology · 202d
Cleared Jun 26, 1997
THERATRON 780E
K964606
Theratronics, Inc.
Radiology · 220d
Cleared May 20, 1997
OUR ROTATING GAMMA SYSTEM
K970647
Our Scientific Intl., Inc.
Radiology · 89d
Cleared Jun 03, 1996
THE COBALT SCALPEL
K960892
Nova Therapeutic System
Radiology · 90d
Cleared Nov 20, 1995
LEKSELL GAMMA UNIT MODEL 23004,TYPE B.
K924849
Elekta Radiosurgery, Inc.
Radiology · 1148d
Cleared Jan 04, 1993
DPD-510 THERAPEUTIC RADIATION DOSIMETER
K925133
Scanditronix, Inc.
Radiology · 83d
Cleared Jan 23, 1992
LEKSELL GAMMAPLAN (LGP)
K914808
Elekta Instruments, Inc.
Radiology · 90d
Cleared Nov 05, 1991
ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES
K912250
Theta Systems, Inc.
Radiology · 168d
Cleared Feb 01, 1990
THERATRON 1000
K894165
Theratronics, Inc.
Radiology · 230d
Cleared Apr 06, 1987
DISPOSABLE SHADOW TRAY INSERTS
K871215
Mick Radio-Nuclear Instruments, Inc.
Radiology · 11d
Cleared Oct 27, 1986
THERATRON-PHOENIX
K863180
Aecl Medical
Radiology · 70d
Cleared Apr 08, 1986
MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM
K860849
Marx Pland
Radiology · 33d
Cleared May 10, 1985
THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY
K850543
Atomic Energy of Canada
Radiology · 88d
Cleared Sep 29, 1982
STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE
K827583
Nucletronix, Inc.
Radiology · 30d
Cleared Jun 22, 1978
SYSTEM, PLANNING, TREATMENT
K780948
Emi Therapy Systems, Inc.
Radiology · 13d