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Varian Medical Systems, Inc.

FDA 510(k) & PMA Approved Devices — 83 products

Total Devices83
Categories9
Latest Approval2026-04-23
TypeNumberDevice NameCodeDate
510(k) K252815 ProBeam 360 Proton Therapy System v3.0 LHN 2026-04-23 View
510(k) K252304 syngo.via RT Image Suite VC10 MUJ 2026-03-18 View
510(k) K252977 Halcyon, Ethos Radiotherapy System (5.0) IYE 2026-01-21 View
510(k) K252919 IDENTIFY (5.0) IYE 2025-12-16 View
510(k) K252948 TrueBeam, TrueBeam STX, Edge and VitalBeam IYE 2025-10-07 View
510(k) K250299 CT/ MR Tandem and Ovoid Set JAQ 2025-05-09 View
510(k) K243939 Titanium Flexible Geometry FSD Applicator Set (GM11013400) JAQ 2025-03-03 View
510(k) K242957 Identify (4.0) IYE 2025-02-07 View
510(k) K242608 Embozene Color-Advanced Microspheres KRD 2025-01-17 View
510(k) K241764 Mould Probe MR Safe JAQ 2025-01-10 View
510(k) K242463 ARIA Radiation Therapy Management System (18.1) MUJ 2024-12-13 View
510(k) K242874 Gating Reflector Block JAK 2024-11-21 View
510(k) K241853 Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve JAQ 2024-11-07 View
510(k) K242794 ONCOZENE Microspheres KRD 2024-10-16 View
510(k) K241386 Heyman Packing Applicator Set (GM11004580) JAQ 2024-08-30 View
510(k) K240480 IntelliBlate 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) NEY 2024-07-19 View
510(k) K240784 Temperature Sensor Probe (ABL-18TP20) NEY 2024-05-29 View
510(k) K240495 Flexible Fixation Device for Gynecological Applicators (GM11001960) JAQ 2024-05-09 View
510(k) K232923 Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) IYE 2024-04-30 View
510(k) K232623 Universal Endometrial Applicator Set (GM11009840) JAQ 2024-04-09 View
510(k) K232949 Kelowna GYN and Crook Prostate Templates JAQ 2024-02-01 View
510(k) K232870 TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) IYE 2023-12-21 View
510(k) K232113 Halcyon, Ethos Radiotherapy System IYE 2023-11-03 View
510(k) K231863 ProBeam 360° Proton Therapy System v2.0 (Multiroom) LHN 2023-10-06 View
510(k) K231317 TrueBeam, TrueBeam STx, Edge, VitalBeam IYE 2023-09-12 View
510(k) K230576 IDENTIFY IYE 2023-07-25 View
510(k) K230557 Eclipse Treatment Planning System (v18.0) MUJ 2023-05-26 View
510(k) K223839 TrueBeam, TrueBeam STx, Edge, VitalBeam IYE 2023-05-22 View
510(k) K230699 ARIA Radiation Therapy Management (v18.0) IYE 2023-04-10 View
510(k) K230271 ISOLIS Cryoprobe GEH 2023-03-28 View
510(k) K222775 Aarhus Applicator Set JAQ 2023-03-13 View
510(k) K222941 Halcyon, Ethos Radiotherapy System IYE 2023-01-17 View
510(k) K221791 ProBeam 360° Proton Therapy System LHN 2022-12-01 View
510(k) K221797 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device JAQ 2022-09-14 View
510(k) K221408 ARIA Radiation Therapy Management (v16.1 MR3) IYE 2022-06-17 View
510(k) K221448 ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) IYE 2022-06-15 View
510(k) K213977 TrueBeam, TrueBeam STx, Edge, VitalBeam IYE 2022-06-03 View
510(k) K213927 Respiratory Gating for Scanners v2.0 JAK 2022-01-14 View
510(k) K211149 Urethral Warming Catheter Kit GEH 2022-01-05 View
510(k) K211881 AI Segmentation MUJ 2021-09-02 View
510(k) K212294 Ethos Treatment Management, Ethos Treatment Planning IYE 2021-08-20 View
510(k) K210835 Identify IYE 2021-04-20 View
510(k) K203469 AI Segmentation MUJ 2021-04-19 View
510(k) K203766 4D Integrated Treatment Console MUJ 2021-02-12 View
510(k) K203669 Mobius3D IYE 2021-01-14 View
510(k) K193240 Universal Cylinder Applicator Family JAQ 2020-08-17 View
510(k) K201588 CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice GEH 2020-08-11 View
510(k) K201607 Eclipse Treatment Planning System v16.1 MUJ 2020-07-10 View
510(k) K200608 Eclipse Treatment Planning System v16.0 MUJ 2020-04-03 View
510(k) K192377 Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon IYE 2020-02-10 View
510(k) K192968 IDENTIFY IYE 2019-11-12 View
510(k) K192424 Mobius3D IYE 2019-10-03 View
510(k) K191761 Mobius3D IYE 2019-07-31 View
510(k) K190137 Identify IYE 2019-07-10 View
510(k) K191580 BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device JAQ 2019-07-08 View
510(k) K172533 GM Implant Tubes, Length Cutting Gauge JAQ 2018-10-22 View
510(k) K181903 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device JAQ 2018-10-03 View
510(k) K181404 Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator IYE 2018-06-28 View
510(k) K181145 Eclipse Treatment Planning System MUJ 2018-05-18 View
510(k) K172675 Varian Cervical Sleeves JAQ 2018-05-16 View
510(k) K181032 Halcyon IYE 2018-05-09 View
510(k) K170570 Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung IYE 2018-04-06 View
510(k) K180586 Varian Head Frame IYE 2018-04-02 View
510(k) K172611 Universal 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 lengths JAQ 2018-03-21 View
510(k) K173636 Velocity LLZ 2018-02-15 View
510(k) K171631 Standard Catheter Set JAQ 2018-02-09 View
510(k) K173838 ARIA Radiation Therapy Management IYE 2018-01-17 View
510(k) K162533 Kelowna GYN and Crook Prostate Templates JAQ 2017-08-31 View
510(k) K172163 Eclipse Treatment Planning System MUJ 2017-08-15 View
510(k) K172013 VitalBeam IYE 2017-07-28 View
510(k) K171733 TrueBeam, TrueBeam STx, Edge IYE 2017-07-12 View
510(k) K170969 Eclipse Treatment Planning System MUJ 2017-07-05 View
510(k) K170817 Halcyon IYE 2017-06-27 View
510(k) K162615 Mould Applicator Set JAQ 2017-03-24 View
510(k) K160815 Interstitial Needles JAQ 2017-03-10 View
510(k) K162018 Surface Applicator Set JAQ 2017-02-28 View
510(k) K162472 TrueBeam-TrueBeam STx-Edge IYE 2017-01-19 View
510(k) K162476 Varian High Energy Linear Accelerator IYE 2016-12-12 View
510(k) K160045 Heyman Packing Applicator Set JAQ 2016-11-17 View
510(k) K161540 Advanced Breast Template System JAQ 2016-10-20 View
510(k) K161576 Esophagus Bougie Set JAQ 2016-10-02 View
510(k) K160516 Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths JAQ 2016-08-10 View
510(k) K160021 Varian Sterilization Boxes JAQ 2016-04-13 View
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