FDA 510(k) Applications for Medical Device Product Code "IWB"
(System, Radiation Therapy, Radionuclide)

FDA 510(k) Number Applicant Device Name Decision Date
K000478 ACCURAY, INC. THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 04/19/2000
K984563 ACCURAY, INC. THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY 07/14/1999
K863180 AECL MEDICAL "THERATRON-PHOENIX" 10/27/1986
K060314 AMERICAN RADIOSURGERY, INC. ROTATING GAMMA SYSTEM. GAMMA ART-6000 04/06/2006
K850543 ATOMIC ENERGY OF CANADA THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY 05/10/1985
K142219 Best Theratronics Limited GammaBeam 100 11/13/2014
K150191 Best Theratronics Limited GammaBeam 500 04/17/2015
K092083 ELEKTA INSTRUMENT AB EXTEND FRAME SYSTEM, MODEL 1009633 09/22/2009
K051022 ELEKTA INSTRUMENT AB GAMMAPLAN 06/01/2005
K151561 ELEKTA INSTRUMENT AB Leksell Gamma Knife Icon 08/04/2015
K160440 Elekta Instrument AB Leksell Gamma Knife Icon 04/20/2016
K151159 ELEKTA INSTRUMENT AB Leksell Gamma Knife Perfexion 10/29/2015
K120811 ELEKTA INSTRUMENT AB LEKSELL GAMMA KNIFE PERFEXION 05/24/2012
K133565 ELEKTA INSTRUMENT AB LEKSELL GAMMA KNIFE PERFEXION 05/09/2014
K063512 ELEKTA INSTRUMENT AB LEKSELL GAMMA KNIFE PERFEXION 03/05/2007
K173789 Elekta Instrument AB Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon 03/30/2018
K061941 ELEKTA INSTRUMENT AB LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 08/21/2006
K984328 ELEKTA INSTRUMENT AB LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 05/21/1999
K173791 Elekta Instrument AB Leksell GammaPlan 02/09/2018
K061540 ELEKTA INSTRUMENT AB LEKSELL GAMMAPLAN 07/05/2006
K914808 ELEKTA INSTRUMENTS, INC. LEKSELL GAMMAPLAN (LGP) 01/23/1992
K924849 ELEKTA RADIOSURGERY, INC. LEKSELL GAMMA UNIT MODEL 23004,TYPE B. 11/20/1995
K780948 EMI THERAPY SYSTEMS, INC. SYSTEM, PLANNING, TREATMENT 06/22/1978
K131777 HYPER TECHNOLOGY INC HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM 02/28/2014
K860849 MARX PLAND MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM 04/08/1986
K041125 MASEP MED SCIENCE & TECH. DEVELOPMENT (SHENZHEN) C MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) 12/30/2004
K102533 MASEP MEDICAL SCIENCE & TECH.DEVELOPMENT (SHENZHEN ROTATING GAMMA SYSTEM INFINI (INFINI) 03/22/2011
K001006 MDS NORDION THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE 04/27/2000
K053485 MDS NORDION INC. THERATRON EQUINOX, MODELS 80 CM AND 100 CM 03/09/2006
K871215 MICK RADIO-NUCLEAR INSTRUMENTS, INC. DISPOSABLE SHADOW TRAY INSERTS 04/06/1987
K960892 NOVA THERAPEUTIC SYSTEM THE COBALT SCALPEL 06/03/1996
K827583 NUCLETRONIX, INC. STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE 09/29/1982
K970647 OUR SCIENTIFIC INTL., INC. OUR ROTATING GAMMA SYSTEM 05/20/1997
K973441 PATTERSON CONSULTING GROUP, INC. LEKSELL GAMMAPLAN 04/01/1998
K925133 SCANDITRONIX, INC. DPD-510 THERAPEUTIC RADIATION DOSIMETER 01/04/1993
K894165 THERATRONICS, INC. THERATRON 1000 02/01/1990
K964606 THERATRONICS, INC. THERATRON 780E 06/26/1997
K983917 THERATRONICS, INC. THERATRON ELITE 12/04/1998
K912250 THETA SYSTEMS, INC. ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES 11/05/1991
K180571 Xcision Medical Systems, LLC GammaPod 04/04/2018
K172706 Xcision Medical Systems, LLC GammaPod - Model A 12/22/2017


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