ClearanceBrief
Panels › Radiology › Product code IYE · Class 2

Accelerator, Linear, Medical

Regulation 892.5050

15510(k)s in 12 months (738 all time)
8recalls in 12 months (563 all time)
542recalls that name a 510(k)
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Top companies in IYE

Company510(k)sRecalls
Siemens Medical Solutions USA, Inc.18206
Varian Medical Systems8327
Elekta , Ltd.1977
Varian Medical Systems, Oncology Systems268
Accuray Incorporated1932
Landauer139
Brainlab2217
Varian Assoc., Inc.270
Medtec, Inc.200
Sun Nuclear Corp.191
Decided510(k)Device and applicantCode
Dec 5, 2012K121663CLARITY
Elekta , Ltd., CA
IYE
Oct 26, 2012K122137CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM
Accuray Incorporated
IYE
Oct 23, 2012K121657PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR
Proton Systems
IYE
Oct 19, 2012K121845SDX SYSTEM
Dyn'R Sas, FR
IYE
Oct 3, 2012K122450MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS
Mitsubishi Heavy Industries, Ltd., JP
IYE
Sep 28, 2012K122451EXACTRAC VERO
Brainlab AG, DE
IYE
Aug 29, 2012K121934TOMOTHERAPY TREATMENT SYSTEM
Accuray Incorporated
IYE
Aug 14, 2012K120789EXACTRAC X-RAY X-RAY
Brainlab AG, DE
IYE
Aug 3, 2012K112692IDENTIFY
Humediq GmbH, DE
IYE
Jul 30, 2012K120668SENTINEL
C-Rad Positioning AB, SE
IYE
Jun 27, 2012K121295ARTISTETM SOLUTION WITH SYS VCIO
Siemens Medical Solutions USA, Inc.
IYE
Jun 20, 2012K121530BODYFIX SYSTEM
Medical Intelligence Medizintechnik GmbH, DE
IYE
Jun 12, 2012K121328AGILITY
Elekta , Ltd., GB
IYE
May 22, 2012K111862VIEWRAY SYSTEM
Viewray, Incorporated
IYE
May 3, 2012K120335EMBRACE THERMOPLASTIC
Bionix Development Corp.
IYE
Apr 19, 2012K112286NOVAC 11
New Radiant Technology S.P.A.
IYE
Apr 17, 2012K110840LIAC
Sordina S.P.A.
IYE
Mar 9, 2012K120233SYNCHRONY RESPIRATORY TRACKING SYSTEM
Accuray Incorporated
IYE
Feb 28, 2012K120067MOSAIQ ONCOLOGY INFORMATION SYSTEM
Impac Medical Systems, Inc.
IYE
Feb 27, 2012K113276CATALYST
C-Rad Positioning AB, SE
IYE
Feb 16, 2012K112841SURFACE BEACON TRANSPONDERS
Calypso Medical Technologies, Inc.
IYE
Jan 30, 2012K111332CLARITY OBP SYSTEM
Elekta , Ltd., CA
IYE
Jan 10, 2012K113758VOLUSON E6/E8/E8EXPERT/E10
GE Healthcare
IYE
Jan 10, 2012K110971TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT
Navotek Medical, Ltd.
IYE
Dec 29, 2011K112778SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING
Varian Medical Systems
IYE
Dec 16, 2011K112613INTEGRITY(TM)
Elekta Limited, GB
IYE
Nov 22, 2011K112210FRAXION
Medical Intelligence Medizintechnik GmbH, DE
IYE
Nov 14, 2011K112839VARIAN HIGH ENERGY LINEAR ACCELERATOR
Varian Medical Systems
IYE
Oct 7, 2011K112460MULTIPLE
Larson Medical Products, Inc.
IYE
Aug 18, 2011K111106TRUEBEAM
Varian Medical Systems, Inc.
IYE
Apr 28, 2011K110772BIOMARC FIDUCIAL MARKER
Carbon Medical Technologies, Inc.
IYE
Apr 15, 2011K103606ARTISTE SOLUTION WITH SYS_VB50 UPDATE
Siemens Medical Solutions USA, Inc.
IYE
Jan 25, 2011K103616PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER
Aktina Medical Physics Corp.
IYE
Jan 21, 2011K100625REALEYE MODEL VCPS
Navotek Medical, Ltd.
IYE
Jan 12, 2011K103394BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)
Varian Medical Systems, Oncology Systems
IYE
Dec 27, 2010K103193DOSEVIEW 3D
Standard Imaging, Inc.
IYE
Dec 7, 2010K102765PRONEX
Direx Systems Corp.
IYE
Nov 23, 2010K102237PVS MODEL 1.0
Medcom GmbH, DE
IYE
Nov 17, 2010K102650CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
Accuray Incorporated
IYE
Nov 4, 2010K102200INTEGRITY MODEL 1014284
Elekta , Ltd., GB
IYE
Nov 2, 2010K102583MUCHECK, VERSION 9.0
Oncology Data Systems, Inc.
IYE
Oct 15, 2010K102024RPM RESPIRATORY GATING SYSTEM
Varian Medical Systems
IYE
Oct 12, 2010K102671SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2
Siemens Medical Solutions USA, Inc.
IYE
Oct 1, 2010K1019923D SCANNER, MODEL 1230
Sun Nuclear Corp.
IYE
Aug 10, 2010K101751VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR
Varian Medical Systems, Oncology Systems
IYE
Aug 4, 2010K101503DUSIMETRY CHECK
Math Resolutions, LLC
IYE
Jul 13, 2010K100890VARIAN HIGH ENERGY LINEAR ACCELERATOR
Varian Medical Systems
IYE
Jul 12, 2010K093967VARIAN TREATMENT
Varian Medical Systems, Inc.
IYE
Jun 18, 2010K100801PUMA MODEL VERSION 1.0
Prowess, Inc.
IYE
Jun 17, 2010K101131FIDUCIAL MARKERS
Cosman Medical, Inc.
IYE

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