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IYE

735 FDA 510(k) clearances · Product code

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RecordFirmDate
XVI R4.5 (K100115)Elekta , Ltd.2010-03-10
P-ART, MODEL 001 (K092424)P-Cure, Ltd.2010-03-05
FLEXIMARC, MODEL CM-0.9-2-10-GG-L (K100267)Cortex Manufacturing, Inc.2010-02-24
RESPISENS (K092845)Nomics2010-01-26
SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL (K092479)Dyn'R2010-01-11
TIGRT IVS (K092550)Linatech, LLC2009-12-15
ARIA RADIATION ONCOLOGY WITH MIRS (K093527)Varian Medical Systems, Inc.2009-12-15
TRILOGY MX (K092871)Varian Medical Systems, Inc.2009-11-30
PATLOG 2.0 (K092939)Oncolog Medical QA AB2009-10-09
STELLAR FIDUCIAL MARKER, MODEL GFMIA (K092041)Stellar Medical, LLC2009-10-02
OMNIPRO INCLINE (K092018)Iba Dosimetry GmbH2009-09-18
160MLC OPTION (K092145)Siemens Medical Solutions USA, Inc.2009-09-18
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K091999)Accuray, Inc.2009-09-18
MODEL 1014 PC ELECTROMETER (K092019)Sun Nuclear Corp.2009-09-15
PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90 (K092285)Best Medical Canada , Ltd.2009-08-28
GOLD ANCHOR (K091645)Naslund Medical AB2009-07-21
TIGRT MLC, TIGRT DMLC (K090802)Linatech, LLC2009-07-07
PORTALVISION ADVANCED IMAGING (K091209)Varian Medical Systems, Inc.2009-06-23
MUCHECK V8 (K091602)Oncology Data Systems, Inc.2009-06-18
4D INTEGRATED TREATMENT CONSOLE (K091132)Varian Medical Systems2009-06-17
SYNGO RT THERAPIST CONNECT (K090683)Siemens Medical Solutions USA, Inc.2009-05-08
SENTINEL, MODEL SP-001 (K082582)C-Rad Positioning AB2009-03-30
CLEARVUE PRONE BREAST TREATMENT TABLE (K090349)Orbital Therapy, LLC2009-03-09
PRESCISION OPTION (K082775)Siemens Medical Solutions USA, Inc.2009-02-19
PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C (K090044)Oncolog Medical QA AB2009-01-22
RSVP HALF SPHERE PHANTOM, MODEL DDP010 (K082909)The Phantom Laboratory, Inc.2008-12-23
STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 (K082773)Standard Imaging, Inc.2008-11-19
STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 (K081935)Aktina Medical Physics Corp.2008-10-07
MLCI2 (K082122)Elekta , Ltd.2008-08-29
MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM (K081859)Sicel Technologies, Inc.2008-08-04
RSVP PHANTOM PELVIS, MODEL TLP260 (K081760)The Phantom Laboratory, Inc.2008-07-29
BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST (K081218)It-V Medizintechnik, GmbH2008-07-21
TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE (K081188)Varian Medical Systems, Inc.2008-07-14
DESKTOP PRO (K080585)Elekta , Ltd.2008-06-11
MRI PATIENT POSITIONING DEVICES (K080072)CIVCO Medical Instruments Co., Inc.2008-06-04
CALYPSO 4D LOCALIZATION SYSTEM (K080726)Calypso Medical Technologies, Inc.2008-05-14
4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) (K081036)Varian Medical Systems, Inc.2008-05-09
VERISUITE 1.6, VERISUITE-PARTICLE 1.6 (K080742)Medcom GmbH2008-05-09
STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT (K073018)Brainlab AG2008-01-23
ARTISTE MV SA (K072485)Siemens Medical Solutions USA, Inc.2007-12-27
EQUAL DOSE 1.0 (K073273)Nucletron Corporation2007-12-11
COMPASS (K072374)Scanditronix Wellhofer GmbH2007-12-07
TRILOGY SYSTEM WITH RAPIDARC (K072916)Varian Medical Systems, Inc.2007-11-09
EXACTRAC 5.5 (K072506)Brainlab AG2007-10-26
TRACKPORT (K072529)Direx Systems Corp.2007-10-26
EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM (K072046)Brainlab AG2007-10-17
INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS (K072454)Integra Radionics, Inc.2007-10-16
GATECT-RT (K072171)Vision RT Limited2007-10-01
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K072504)Accuray Incorporated2007-09-21
FIDUCIAL MARKERS (K071614)Civco2007-09-11
MHI-TM2000 LINEAR ACCELERATOR SYSTEM (K072047)Mitsubishi Heavy Industries, Ltd.2007-08-29
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K071531)Accuray Incorporated2007-08-22
HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) (K071992)Varian Medical Systems2007-08-15
IGUIDE SYSTEM (K072079)Medical Intelligence Medizintechnik-GmbH-An Elekta2007-08-14
TRACKLEAF-10 (K071701)Direx Systems Corp.2007-07-23
ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032 (K071673)Onc Solutions, Inc.2007-07-18
BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6 (K070611)Nomos Corp.2007-07-11
OPTICAL GUIDANCE PLATFORM (K071360)Varian Medical Systems, Inc.2007-06-08
FUJI IP CASSETTE TYPE PC (K070920)Fujifilm Medical Systems U.S.A, Inc.2007-05-22
PRE-LOADED VISICOIL (K070305)Radiomed Corporation2007-03-07
TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM (K070094)Varian Medical Systems, Inc.2007-02-09
POSITIONER (K063839)C-Rad Positioning AB2007-02-08
RPM RESPIRATORY GATING SYSTEM (K063270)Varian Medical Systems, Inc.2006-12-14
ACCULOC BREAST LOCALIZATION SYSTEM (K063274)Northwest Medical Physics Equipment, Inc.2006-12-12
PROFILER 2 (K063021)Sun Nuclear Corp.2006-11-22
PTW DAVID IMRT QC VERIFICATION SYSTEM (K062817)Ptw-New York Corp.2006-11-22
TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT (K062618)Varian Medical Systems, Inc.2006-09-22
IGUIDE SYSTEM (K062611)Medical Intelligence Medizintechnik-GmbH-An Elekta2006-09-20
CALYPSO 4D LOCALIZATION SYSTEM (K060906)Calypso Medical Technologies, Inc.2006-07-28
MAGIS1;MAGIS2 (K061713)Direx Systems Corp.2006-07-21
NOMOSSTAT, VERSION 1.0 (K060895)Nomos Corp.2006-07-21
TRILOGY RADIOTHERAPY DELIVERY SYSTEM (K061140)Varian Medical Systems2006-05-15
COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0 (K060633)Siemens Medical Solutions USA, Inc.2006-05-01
MODIFICATION TO: HI-ART SYSTEM (K060912)Tomotherapy Incorporated2006-04-19
SINMED POSITIONING DEVICES (K060737)Sinmed BV2006-03-31
ONCOR EXPRESSION (K060226)Siemens Medical Solutions USA, Inc.2006-03-15
MIGUE (K052212)Direx Systems Corp.2006-03-10
DART-12 (K052705)Direx Systems Corp.2006-02-21
FRAMELESS RADIOSURGERY COMPONENTS (K053500)Brainlab AG2006-02-03
DELTA4 (K052920)Scandidos AB2006-01-12
ALIGNRT (K052682)Vision RT Limited2006-01-06
VISION (WITH OFF-LINE REVIEW) (K052391)Varian Medical Systems2005-11-23
IPLAN RT FIBERTRACKING (K052220)Brainlab AG2005-09-30
ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 (K051932)Elekta, Inc.2005-08-12
THE EDGE DETECTOR, MODEL 1118 (K051921)Sun Nuclear Corp.2005-07-27
NAVIGATOR (K042875)Nomos Corp.2005-07-01
INTEGRA IMMOBILIZATION SYSTEM (K050888)Diacor, Inc.2005-05-23
ACCUCHANGER (K043409)Direx Systems Corp.2005-05-05
THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 (K050701)Bionix Development Corp.2005-04-01
VISITRAK, VERSION 1, RELEASE 1 (K050372)Math Resolutions, LLC2005-03-25
4D INTEGRATED TREATMENT CONSOLE (K050479)Varian Medical Systems2005-03-24
MILLENNIUM MULTI-LEAF COLLIMATOR (K050442)Varian Medical Systems2005-03-23
VISION (K042956)Varian Medical Systems, Inc.2005-03-11
BEAM MODULATOR, MODEL 4513 332 8000 (K042794)Elekta , Ltd.2005-01-31
RESTITU (K041937)Resonant Medical, Inc.2004-11-16
ON-BOARD IMAGER DEVICE (K042720)Varian Medical Systems2004-10-29
MODIFICATION TO: ON-BOARD IMAGER DEVICE (K041519)Varian Medical Systems, Inc.2004-08-04
MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W (K041557)Thomson & Nielsen Electronics, Ltd.2004-06-25
ONEDOSE PATIENT DOSIMETRY SYSTEM (K040687)Sicel Technologies, Inc.2004-06-25
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY (K041315)Accuray, Inc.2004-06-10
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