FDA.reportPublic FDA data

Varian Medical Systems, Inc

Matched from indexed company URL: Varian Medical Systems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29167102916710Varian Medical Systems, Inc1N2026-01-01911 Hansen Way PALO ALTO CA US 94304
30071572553007157255Varian Medical Systems, Inc.1N2026-01-013290 Northside Parkway NW Suite 400 Atlanta GA US 30327
30077915413007791541Varian Medical Systems China Co., Ltd.1N2026-01-01No. 8 Yuncheng Street BDA Beijing CN 100176
30082627153008262715Varian Medical Systems, Inc1N2026-01-019825 Spectrum Drive, Building 2 Austin TX US 78717
30101235253010123525Varian Medical Systems Hungary Kft.1N2026-01-01Csorsz utca 45 Budapest HU 1124
30106588953010658895Varian Medical Systems Particle Therapy GmbH & Co. KG1N2026-01-01Landgrafenstrasse 106-114 Troisdorf North Rhine-Westphalia DE D-53842
30155486633015548663Varian Medical Systems, Inc.1N2026-01-016212 Hellyer Ave San Jose CA US 95138
30166028743016602874Varian Medical Systems Haan GmbH1N2026-01-01Rheinische Strasse 2 Haan North Rhine-Westphalia DE 42781
30229772433022977243Varian Medical Systems, Inc.1N2026-01-013550 Lexington Ave N Ste 300 Shoreview MN US 55126
11247913000206172Varian Medical Systems, Inc.1N2020-04-25501 Locust Ave Ste 1 CHARLOTTESVILLE VA US 22902
96126383003111535Varian Medical Systems Haan GmbH1N2020-04-25Bergische Strasse 16 Haan Nordrhein-Westfalen DE 42781
30048379483004837948Varian Medical Systems1N2020-04-252101 4th Avenue, Suite 100 SEATTLE WA US 98121
30088892063008889206Varian Medical Systems Particle Therapy GmbH1N2020-04-25Mottmannstrasse.2 Troisdorf Nordrhein-Westfalen DE D-53842

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
80172066776685K983436GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEMJAQ1998-10-29
2865902066776685K983436GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEMJAQ1998-10-29
80171304007073K980576VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADERJAQ1998-11-02
80171710599049K955844APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADERJAQ1996-07-26
80241710599049K955844APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADERJAQ1996-07-26
2865901710599049K955844APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADERJAQ1996-07-26
80171549606951K952913APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADERJAQ1995-11-22
2865901549606951K952913APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADERJAQ1995-11-22
80221931293561K926321VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D)IYE1994-08-09
80221091207482K252977Halcyon, Ethos Radiotherapy System (5.0)IYE2026-01-21
1047891091207482K252977Halcyon, Ethos Radiotherapy System (5.0)IYE2026-01-21
80222005441338K252948TrueBeam, TrueBeam STX, Edge and VitalBeamIYE2025-10-07
2865901814783113K252919IDENTIFY (5.0)IYE2025-12-16
2865901678007406K252884Guided Aarhus Applicator SetJAQ2025-11-19
1664361103841373K252815ProBeam 360 Proton Therapy System v3.0LHN2026-04-23
2865901946381438K252717MAASTRO Rectal Applicator SetJAQ2026-05-20
2865901966649089K250299CT/ MR Tandem and Ovoid SetJAQ2025-05-09
2865901042623217K250289Intracavitary/Interstitial SystemJAQ2025-04-25
80221977076667K250099Mobius3D (4.1)IYE2025-05-16
2865901513172565K243939Titanium Flexible Geometry FSD Applicator Set (GM11013400)JAQ2025-03-03
2865901180152196K242961Intraluminal Applicator SetJAQ2024-11-26
2865901932163241K242957Identify (4.0)IYE2025-02-07
2374961089275410K242794ONCOZENE MicrospheresKRD2024-10-16
2374962041724592K242608Embozene Color-Advanced MicrospheresKRD2025-01-17
2893421481398843K242463ARIA Radiation Therapy Management System (18.1)MUJ2024-12-13
2865902063174553K241965Catheter Surface Flap Applicator Set (GM11011830)JAQ2024-10-29
2865901884861744K241876Vitesse (5.0)MUJ2024-10-23
2865901212718075K241853Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical SleeveJAQ2024-11-07
2865901105385188K241764Mould Probe MR SafeJAQ2025-01-10
2865901320428345K241386Heyman Packing Applicator Set (GM11004580)JAQ2024-08-30
2374961455468241K240784Temperature Sensor Probe (ABL-18TP20)NEY2024-05-29
3305051455468241K240784Temperature Sensor Probe (ABL-18TP20)NEY2024-05-29
2865901811696676K240495Flexible Fixation Device for Gynecological Applicators (GM11001960)JAQ2024-05-09
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
3305051690890936K240480IntelliBlate 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
2865901843495179K232949Kelowna GYN and Crook Prostate TemplatesJAQ2024-02-01
80221654380699K232870TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)IYE2023-12-21
2865901889747911K232623Universal Endometrial Applicator Set (GM11009840)JAQ2024-04-09
2865902034810465K232400VariSeed (v10)MUJ2023-09-08
80221300266629K232113Halcyon, Ethos Radiotherapy SystemIYE2023-11-03
1047891300266629K232113Halcyon, Ethos Radiotherapy SystemIYE2023-11-03
1664361561228689K231863ProBeam 360° Proton Therapy System v2.0 (Multiroom)LHN2023-10-06
80221337367726K231317TrueBeam, TrueBeam STx, Edge, VitalBeamIYE2023-09-12
2893421836418789K230699ARIA Radiation Therapy Management (v18.0)IYE2023-04-10
2865901297393525K230576IDENTIFYIYE2023-07-25
2374961647880782K230271ISOLIS CryoprobeGEH2023-03-28
2374961181219989K230015OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power DriverKNW2023-06-16
3305051181219989K230015OmniBone™ 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
1047891778250232K222941Halcyon, Ethos Radiotherapy SystemIYE2023-01-17
2865901431440751K222775Aarhus Applicator SetJAQ2023-03-13
2865901827107158K221797BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment DeviceJAQ2022-09-14
1664361046995534K221791ProBeam 360° Proton Therapy SystemLHN2022-12-01
2893421356879613K221408ARIA Radiation Therapy Management (v16.1 MR3)IYE2022-06-17
80221048174529K213977TrueBeam, TrueBeam STx, Edge, VitalBeamIYE2022-06-03
2840971048174529K213977TrueBeam, TrueBeam STx, Edge, VitalBeamIYE2022-06-03
2893421023132637K213927Respiratory Gating for Scanners v2.0JAK2022-01-14
2374961451201885K211149Urethral Warming Catheter KitGEH2022-01-05
80221362095603K2037664D Integrated Treatment ConsoleMUJ2021-02-12
80221314794691K203669Mobius3DIYE2021-01-14
2865901866205990K201607Eclipse Treatment Planning System v16.1MUJ2020-07-10
2374961653315855K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round IceGEH2020-08-11
80241016460499K200608Eclipse Treatment Planning System v16.0MUJ2020-04-03
80241134592023K200608Eclipse Treatment Planning System v16.0MUJ2020-04-03
2865901302095225K193240Universal Cylinder Applicator FamilyJAQ2020-08-17
2374961109269892K192504Treace Medical Concepts (TMC) Plating SystemHRS2019-10-30
80222072822009K192424Mobius3DIYE2019-10-03
80221053686007K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonIYE2020-02-10
1047891053686007K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonIYE2020-02-10
80171347290305K191580BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment DeviceJAQ2019-07-08
2865901347290305K191580BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment DeviceJAQ2019-07-08
2374961922278849K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemHWC2019-06-13
80171776352323K181903BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment DeviceJAQ2018-10-03
80221217316999K181404Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf CollimatorIYE2018-06-28
1047891217316999K181404Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf CollimatorIYE2018-06-28
80241281255750K181145Eclipse Treatment Planning SystemMUJ2018-05-18
80221086934450K181032HalcyonIYE2018-05-09
1047891086934450K181032HalcyonIYE2018-05-09
80221828982624K180586Varian Head FrameIYE2018-04-02
2840971828982624K180586Varian Head FrameIYE2018-04-02
2374961349016954K180102Embozene Color-Advanced MicrospheresNOY2018-04-19
2893421882678344K173838ARIA Radiation Therapy ManagementIYE2018-01-17
1751891492189672K173636VelocityLLZ2018-02-15
80171700175433K172675Varian Cervical SleevesJAQ2018-05-16
2865901700175433K172675Varian Cervical SleevesJAQ2018-05-16
2374961312068018K172617Treace Medical Concepts (TMC) Compression Screw SystemHWC2017-10-25
80171261039274K172611Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengthsJAQ2018-03-21
2865901261039274K172611Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengthsJAQ2018-03-21
80171406433534K172533GM Implant Tubes, Length Cutting GaugeJAQ2018-10-22
2865901406433534K172533GM Implant Tubes, Length Cutting GaugeJAQ2018-10-22
80241375057051K172163Eclipse Treatment Planning SystemMUJ2017-08-15
80221311332341K172013VitalBeamIYE2017-07-28
2840971311332341K172013VitalBeamIYE2017-07-28
80221857419727K171733TrueBeam, TrueBeam STx, EdgeIYE2017-07-12
2840971857419727K171733TrueBeam, TrueBeam STx, EdgeIYE2017-07-12
80171311106780K171631Standard Catheter SetJAQ2018-02-09
80241311106780K171631Standard Catheter SetJAQ2018-02-09
2865901311106780K171631Standard Catheter SetJAQ2018-02-09
80221671546825K170817HalcyonIYE2017-06-27
1047891671546825K170817HalcyonIYE2017-06-27
80171831906464K170570Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - LungIYE2018-04-06
1362721831906464K170570Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - LungIYE2018-04-06
2840971831906464K170570Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - LungIYE2018-04-06
2865901831906464K170570Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - LungIYE2018-04-06
80171544017549K162615Mould Applicator SetJAQ2017-03-24
2865901544017549K162615Mould Applicator SetJAQ2017-03-24
80171392635784K162533Kelowna GYN and Crook Prostate TemplatesJAQ2017-08-31
2865901392635784K162533Kelowna GYN and Crook Prostate TemplatesJAQ2017-08-31
80221058997302K162476Varian High Energy Linear AcceleratorIYE2016-12-12
2840971058997302K162476Varian High Energy Linear AcceleratorIYE2016-12-12
80221322545713K162472TrueBeam-TrueBeam STx-EdgeIYE2017-01-19
2840971322545713K162472TrueBeam-TrueBeam STx-EdgeIYE2017-01-19
80171972320814K162018Surface Applicator SetJAQ2017-02-28
2865901972320814K162018Surface Applicator SetJAQ2017-02-28
80171567772316K161576Esophagus Bougie SetJAQ2016-10-02
2865901567772316K161576Esophagus Bougie SetJAQ2016-10-02
80171248151482K161540Advanced Breast Template SystemJAQ2016-10-20
80241248151482K161540Advanced Breast Template SystemJAQ2016-10-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAQ962026-05-20
IYE862026-01-21
MUJ122024-12-13
LHN102026-04-23
GEH72023-03-28
NEY52024-07-19
KRD32025-01-17
LLZ32018-02-15
KXK32015-05-08
KNW22023-06-16
JAK22022-01-14
HWC22019-06-13
HRS12019-10-30
NOY12018-04-19
KPQ12003-12-30

PMN#

IDENTIFY

2023-07-25

Varian Medical Systems, Inc.

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GUDID#

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