FDA.reportPublic FDA data

Varian Medical Systems, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29167102916710Varian Medical Systems, Inc1N2027-01-01911 Hansen Way PALO ALTO CA US 94304
30082627153008262715Varian Medical Systems, Inc1N2027-01-019825 Spectrum Drive, Building 2 Austin TX US 78717

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
80221931293561K926321VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D)IYE1994-08-09
80221091207482K252977Halcyon, Ethos Radiotherapy System (5.0)IYE2026-01-21
80222005441338K252948TrueBeam, TrueBeam STX, Edge and VitalBeamIYE2025-10-07
80221977076667K250099Mobius3D (4.1)IYE2025-05-16
2374961089275410K242794ONCOZENE MicrospheresKRD2024-10-16
2374962041724592K242608Embozene Color-Advanced MicrospheresKRD2025-01-17
2374961455468241K240784Temperature Sensor Probe (ABL-18TP20)NEY2024-05-29
2374961690890936K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)NEY2024-07-19
80221654380699K232870TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)IYE2023-12-21
80221300266629K232113Halcyon, Ethos Radiotherapy SystemIYE2023-11-03
80221337367726K231317TrueBeam, TrueBeam STx, Edge, VitalBeamIYE2023-09-12
2374961647880782K230271ISOLIS CryoprobeGEH2023-03-28
2374961181219989K230015OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power DriverKNW2023-06-16
80221250942358K223839TrueBeam, TrueBeam STx, Edge, VitalBeamIYE2023-05-22
80221778250232K222941Halcyon, Ethos Radiotherapy SystemIYE2023-01-17
80221048174529K213977TrueBeam, TrueBeam STx, Edge, VitalBeamIYE2022-06-03
2374961451201885K211149Urethral Warming Catheter KitGEH2022-01-05
80221362095603K2037664D Integrated Treatment ConsoleMUJ2021-02-12
80221314794691K203669Mobius3DIYE2021-01-14
2374961653315855K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round IceGEH2020-08-11
2374961109269892K192504Treace Medical Concepts (TMC) Plating SystemHRS2019-10-30
80222072822009K192424Mobius3DIYE2019-10-03
80221053686007K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonIYE2020-02-10
2374961922278849K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemHWC2019-06-13
80221217316999K181404Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf CollimatorIYE2018-06-28
80221086934450K181032HalcyonIYE2018-05-09
80221828982624K180586Varian Head FrameIYE2018-04-02
2374961349016954K180102Embozene Color-Advanced MicrospheresNOY2018-04-19
2374961312068018K172617Treace Medical Concepts (TMC) Compression Screw SystemHWC2017-10-25
80221311332341K172013VitalBeamIYE2017-07-28
80221857419727K171733TrueBeam, TrueBeam STx, EdgeIYE2017-07-12
80221671546825K170817HalcyonIYE2017-06-27
80221831906464K170570Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - LungIYE2018-04-06
80221058997302K162476Varian High Energy Linear AcceleratorIYE2016-12-12
80221322545713K162472TrueBeam-TrueBeam STx-EdgeIYE2017-01-19
2374962010284468K153489Cryocare CS Surgical SystemGEH2016-02-05
80221797131429K153014Mobius3DIYE2016-04-29
80221962741187K152761Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G)IYE2015-11-25
2374961933744994K151968Cryocare CS-3 Surgical System version 5GEH2015-09-09
80221239058558K151882Varian Treatment (VTx)IYE2015-10-26
80221006007797K150706VitalBeamIYE2015-05-08
80221874302936K143224TrueBeam-TrueBeam STx-EdgeIYE2014-12-19
80221537563705K142560Varian Head FrameIYE2014-12-11
80222065032989K142268Varian Verification System (VVS)IYE2014-10-02
2374961275549885K141785MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIESNEY2015-03-31
80221712812792K141230DOSELAB PROIYE2014-08-27
2374961590268963K141209EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERESKRD2014-08-07
2374961535346543K141110CRYOCARE CS SURGICAL SYSTEMGEH2015-06-25
80221237958968K140660MOBIUS3DIYE2014-06-24
80222018495038K1333314D INTEGRATED TREATMENT CONSOLEMUJ2014-01-27
80221346384618K133240VARIAN MULTILEAF COLLIMATORIYE2014-01-31
80221292190119K132705UNIQUEIYE2013-10-31
80221643770934K131807HIGH ENERGY LINEAR ACCELERATORIYE2013-10-11
80221042440999K124002VERIFICATION CONSOLELHN2013-02-21
80221461228370K123788INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)IYE2013-01-15
80221344614238K123137CALYPSO SYSTEMIYE2012-12-05
80221474579523K112841SURFACE BEACON TRANSPONDERSIYE2012-02-16
80221223081202K112768CALYPSO SYSTEMS WITH DYNAMIC EDGE GATINGLHN2011-11-18
80221030018037K103394BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)IYE2011-01-12
80221939365845K102024RPM RESPIRATORY GATING SYSTEMIYE2010-10-15
80221894326598K093967VARIAN TREATMENTIYE2010-07-12
80221688408639K071992HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)IYE2007-08-15
80221536436224K033343TRILOGY RADIOTHERAPY DELIVERY SYSTEMIYE2003-12-23
80221984997161K033339ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHYKPQ2003-12-30
2374961483274067K011074CRYOCARE SURGICAL SYSTEMGEH2002-01-25
80221683472889
80221710706144

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYE452026-01-21
GEH72023-03-28
KRD32025-01-17
NEY32024-07-19
MUJ22021-02-12
HWC22019-06-13
LHN22013-02-21
KNW12023-06-16
HRS12019-10-30
NOY12018-04-19
KPQ12003-12-30

PMN#