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IYE

735 FDA 510(k) clearances · Product code

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RecordFirmDate
Active Breathing Coordinator (K151097)Aktina Medical Corporation2015-05-15
VitalBeam (K150706)Varian Medical Systems, Inc.2015-05-08
Patient Positioning Devices (K142420)Macromedics BV2015-03-27
FlexiMarc Marker (K142294)Cortex Manufacturing, Inc.2015-03-26
iGuide 2.1 (K143485)Medical Intelligence Medizintechnik GmbH2015-03-04
TrueBeam-TrueBeam STx-Edge (K143224)Varian Medical Systems, Inc.2014-12-19
Varian Head Frame (K142560)Varian Medical Systems, Inc.2014-12-11
WaterProof PROFILER (K142431)Sun Nuclear Corporation2014-12-05
QUALITY REPORTS (K142142)Sun Nuclear Corporation2014-12-05
ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 (K142434)Siemens Medical Solutions USA, Inc.2014-11-21
CLARITY (K141855)Elekta , Ltd.2014-10-08
Varian Verification System (VVS) (K142268)Varian Medical Systems, Inc.2014-10-02
PERFRACTION (K141800)Sun Nuclear Corporation2014-09-26
TRUE BEAM, TRUE BEAM STX, EDGE (K140528)Varian Medical Systems, Inc.2014-09-05
MOSAIQ ONCOLOGY INFORMATION SYSTEM (K141572)Impac Medical Systems, Inc.2014-09-05
DOSELAB PRO (K141230)Mobius Medical Systems, LP2014-08-27
SAGITTILT (K141787)Orfit Industries NV2014-08-07
PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER (K140823)Varian Medical Systems, Inc.2014-06-27
MOBIUS3D (K140660)Mobius Medical Systems, LP2014-06-24
ARIA RADIATION THERAPY MANAGEMENT (K133572)Varian Medical Systems, Inc.2014-04-04
SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING (K133227)Varian Medical Systems, Inc.2014-03-14
TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT (K132908)Medtec, Inc.2014-03-04
BIOMARC FIDUCIAL MARKER (K132064)Carbon Medical Technologies, Inc.2014-02-28
ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME (K132935)Siemens Medical Solutions USA, Inc.2014-02-21
VARIAN MULTILEAF COLLIMATOR (K133240)Varian Medical Systems, Inc.2014-01-31
DOSIMETRY CHECK VERSION 4 RELEASE 1 (K132605)Math Resolutions, LLC2013-11-14
KLARITY VACUUM BAG, KLARITY MOLD CUSHION (K132124)Klarity Medical Products, LLC2013-11-01
UNIQUE (K132705)Varian Medical Systems, Inc.2013-10-31
HIGH ENERGY LINEAR ACCELERATOR (K131807)Varian Medical Systems, Inc.2013-10-11
NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS (K131795)Orfit Industries NV2013-09-26
XVI R5.0 (K131965)Elekta Limited2013-09-25
3DVH (K131862)Sun Nuclear Corporation2013-08-21
MAPCHECK2, ARCCHECK (K131466)Sun Nuclear Corporation2013-08-20
ACTIVE BREATHING COORDINATOR (K131313)Aktina Medical Corp.2013-08-07
EPIDOSE (K131704)Sun Nuclear Corporation2013-08-05
CHABNER XRT GARMENTS (K121284)Chabner Xrt, LLC2013-06-14
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (K130992)Philips Medical Systems (Cleveland), Inc.2013-06-14
CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM (K122888)Cdr Systems, Inc.2013-04-30
BIOMARC GOLD FIDUCIAL MARKER (K130678)Carbon Medical Technologies, Inc.2013-04-12
AGILITY (K123808)Elekta , Ltd.2013-04-04
COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV (K123812)Siemens Medical Solutions USA, Inc.2013-03-01
INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) (K123788)Varian Medical Systems, Inc.2013-01-15
ALIGNRT PLUS (K123371)Vision RT Limited2013-01-08
PANTHER OIS/R & V MODEL VERSION 2.0 (K122616)Prowess, Inc.2012-12-21
TRUEBEAM (K123291)Varian Medical Systems, Inc.2012-12-20
MOSAIQ ONCOLOGY INFORMATION SYSTEM (K123230)Impac Medical Systems, Inc.2012-12-12
CLARITY (K121663)Elekta , Ltd.2012-12-05
CALYPSO SYSTEM (K123137)Varian Medical Systems2012-12-05
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM (K122137)Accuray Incorporated2012-10-26
PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR (K121657)Proton Systems2012-10-23
SDX SYSTEM (K121845)Dyn'R Sas2012-10-19
MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS (K122450)Mitsubishi Heavy Industries, Ltd.2012-10-03
EXACTRAC VERO (K122451)Brainlab AG2012-09-28
TOMOTHERAPY TREATMENT SYSTEM (K121934)Accuray Incorporated2012-08-29
EXACTRAC X-RAY X-RAY (K120789)Brainlab AG2012-08-14
IDENTIFY (K112692)Humediq GmbH2012-08-03
SENTINEL (K120668)C-Rad Positioning AB2012-07-30
ARTISTETM SOLUTION WITH SYS VCIO (K121295)Siemens Medical Solutions USA, Inc.2012-06-27
BODYFIX SYSTEM (K121530)Medical Intelligence Medizintechnik GmbH2012-06-20
AGILITY (K121328)Elekta , Ltd.2012-06-12
VIEWRAY SYSTEM (K111862)Viewray, Incorporated2012-05-22
EMBRACE THERMOPLASTIC (K120335)Bionix Development Corp.2012-05-03
NOVAC 11 (K112286)New Radiant Technology S.P.A.2012-04-19
LIAC (K110840)Sordina S.P.A.2012-04-17
SYNCHRONY RESPIRATORY TRACKING SYSTEM (K120233)Accuray Incorporated2012-03-09
MOSAIQ ONCOLOGY INFORMATION SYSTEM (K120067)Impac Medical Systems, Inc.2012-02-28
CATALYST (K113276)C-Rad Positioning AB2012-02-27
SURFACE BEACON TRANSPONDERS (K112841)Calypso Medical Technologies, Inc.2012-02-16
CLARITY OBP SYSTEM (K111332)Elekta , Ltd.2012-01-30
TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT (K110971)Navotek Medical, Ltd.2012-01-10
VOLUSON E6/E8/E8EXPERT/E10 (K113758)GE Healthcare2012-01-10
SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING (K112778)Varian Medical Systems2011-12-29
INTEGRITY(TM) (K112613)Elekta Limited2011-12-16
FRAXION (K112210)Medical Intelligence Medizintechnik GmbH2011-11-22
VARIAN HIGH ENERGY LINEAR ACCELERATOR (K112839)Varian Medical Systems2011-11-14
MULTIPLE (K112460)Larson Medical Products, Inc.2011-10-07
TRUEBEAM (K111106)Varian Medical Systems, Inc.2011-08-18
BIOMARC FIDUCIAL MARKER (K110772)Carbon Medical Technologies, Inc.2011-04-28
ARTISTE SOLUTION WITH SYS_VB50 UPDATE (K103606)Siemens Medical Solutions USA, Inc.2011-04-15
PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER (K103616)Aktina Medical Physics Corp.2011-01-25
REALEYE MODEL VCPS (K100625)Navotek Medical, Ltd.2011-01-21
BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV) (K103394)Varian Medical Systems, Oncology Systems2011-01-12
DOSEVIEW 3D (K103193)Standard Imaging, Inc.2010-12-27
PRONEX (K102765)Direx Systems Corp.2010-12-07
PVS MODEL 1.0 (K102237)Medcom GmbH2010-11-23
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K102650)Accuray Incorporated2010-11-17
INTEGRITY MODEL 1014284 (K102200)Elekta , Ltd.2010-11-04
MUCHECK, VERSION 9.0 (K102583)Oncology Data Systems, Inc.2010-11-02
RPM RESPIRATORY GATING SYSTEM (K102024)Varian Medical Systems2010-10-15
SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2 (K102671)Siemens Medical Solutions USA, Inc.2010-10-12
3D SCANNER, MODEL 1230 (K101992)Sun Nuclear Corp.2010-10-01
VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR (K101751)Varian Medical Systems, Oncology Systems2010-08-10
DUSIMETRY CHECK (K101503)Math Resolutions, LLC2010-08-04
VARIAN HIGH ENERGY LINEAR ACCELERATOR (K100890)Varian Medical Systems2010-07-13
VARIAN TREATMENT (K093967)Varian Medical Systems, Inc.2010-07-12
PUMA MODEL VERSION 1.0 (K100801)Prowess, Inc.2010-06-18
FIDUCIAL MARKERS (K101131)Cosman Medical, Inc.2010-06-17
OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 (K100691)Bionix Development Corp.2010-05-11
LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART (K100096)Integra Radionics, Inc.2010-04-22
T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 (K100264)Bionix Development Corp.2010-04-09
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