Halcyon, Ethos Radiotherapy System (5.0)
Varian Medical Systems, Inc.
Varian Medical Systems, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007157255 | 3007157255 | Varian Medical Systems, Inc. | 1 | N | 2026-01-01 | 3290 Northside Parkway NW Suite 400 Atlanta GA US 30327 |
| 3015548663 | 3015548663 | Varian Medical Systems, Inc. | 1 | N | 2026-01-01 | 6212 Hellyer Ave San Jose CA US 95138 |
| 3022977243 | 3022977243 | Varian Medical Systems, Inc. | 1 | N | 2026-01-01 | 3550 Lexington Ave N Ste 300 Shoreview MN US 55126 |
| 1124791 | 3000206172 | Varian Medical Systems, Inc. | 1 | N | 2020-04-25 | 501 Locust Ave Ste 1 CHARLOTTESVILLE VA US 22902 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 8024 | 1710599049 | K955844 | APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER | JAQ | 1996-07-26 |
| 330505 | 1455468241 | K240784 | Temperature Sensor Probe (ABL-18TP20) | NEY | 2024-05-29 |
| 330505 | 1690890936 | 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 |
| 330505 | 1181219989 | K230015 | OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver | KNW | 2023-06-16 |
| 284097 | 1048174529 | K213977 | TrueBeam, TrueBeam STx, Edge, VitalBeam | IYE | 2022-06-03 |
| 8024 | 1016460499 | K200608 | Eclipse Treatment Planning System v16.0 | MUJ | 2020-04-03 |
| 8024 | 1134592023 | K200608 | Eclipse Treatment Planning System v16.0 | MUJ | 2020-04-03 |
| 8024 | 1281255750 | K181145 | Eclipse Treatment Planning System | MUJ | 2018-05-18 |
| 284097 | 1828982624 | K180586 | Varian Head Frame | IYE | 2018-04-02 |
| 175189 | 1492189672 | K173636 | Velocity | LLZ | 2018-02-15 |
| 8024 | 1375057051 | K172163 | Eclipse Treatment Planning System | MUJ | 2017-08-15 |
| 284097 | 1311332341 | K172013 | VitalBeam | IYE | 2017-07-28 |
| 284097 | 1857419727 | K171733 | TrueBeam, TrueBeam STx, Edge | IYE | 2017-07-12 |
| 8024 | 1311106780 | K171631 | Standard Catheter Set | JAQ | 2018-02-09 |
| 284097 | 1831906464 | K170570 | Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung | IYE | 2018-04-06 |
| 284097 | 1058997302 | K162476 | Varian High Energy Linear Accelerator | IYE | 2016-12-12 |
| 284097 | 1322545713 | K162472 | TrueBeam-TrueBeam STx-Edge | IYE | 2017-01-19 |
| 8024 | 1248151482 | K161540 | Advanced Breast Template System | JAQ | 2016-10-20 |
| 8024 | 1383142521 | K160815 | Interstitial Needles | JAQ | 2017-03-10 |
| 284097 | 1962741187 | K152761 | Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) | IYE | 2015-11-25 |
| 284097 | 1006007797 | K150706 | VitalBeam | IYE | 2015-05-08 |
| 8024 | 1336955471 | K150636 | VariSeed 9.0 | KXK | 2015-05-08 |
| 284097 | 1874302936 | K143224 | TrueBeam-TrueBeam STx-Edge | IYE | 2014-12-19 |
| 284097 | 1537563705 | K142560 | Varian Head Frame | IYE | 2014-12-11 |
| 284097 | 1346384618 | K133240 | VARIAN MULTILEAF COLLIMATOR | IYE | 2014-01-31 |
| 284097 | 1643770934 | K131807 | HIGH ENERGY LINEAR ACCELERATOR | IYE | 2013-10-11 |
| 8024 | 1418992818 | K123152 | VITESSE 3.0 | MUJ | 2012-12-07 |
| 8024 | 1430905910 | K122236 | VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER | JAQ | 2012-11-16 |
| 8024 | 1617438958 | K120993 | GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER | JAQ | 2012-07-26 |
| 284097 | 1474579523 | K112841 | SURFACE BEACON TRANSPONDERS | IYE | 2012-02-16 |
| 8024 | 1312415252 | K092822 | CAPRI APPLICATOR | JAQ | 2009-11-03 |
| 175189 | 1014637955 | K081076 | VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE | LLZ | 2008-06-20 |
| 284097 | 1688408639 | K071992 | HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) | IYE | 2007-08-15 |
| 175189 | 1258791022 | K070248 | VELOCITYAIS | LLZ | 2007-03-01 |
| 8024 | 2065993041 | K023220 | VARISOURCE BREAST TEMPLATE SYSTEM | JAQ | 2002-10-25 |
| 284097 | 1683472889 |
Product Codes Associated With Registrations#
PMN#
IDENTIFY (5.0)
Varian Medical Systems, Inc.
CT/ MR Tandem and Ovoid Set
Varian Medical Systems, Inc.
Titanium Flexible Geometry FSD Applicator Set (GM11013400)
Varian Medical Systems, Inc.
Identify (4.0)
Varian Medical Systems, Inc.
Embozene Color-Advanced Microspheres
Varian Medical Systems, Inc.
Mould Probe MR Safe
Varian Medical Systems, Inc.
ARIA Radiation Therapy Management System (18.1)
Varian Medical Systems, Inc.
Gating Reflector Block
Varian Medical Systems, Inc.
Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve
Varian Medical Systems, Inc.
ONCOZENE Microspheres
Varian Medical Systems, Inc.
Heyman Packing Applicator Set (GM11004580)
Varian Medical Systems, Inc.
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); Intel
Varian Medical Systems, Inc.
Temperature Sensor Probe (ABL-18TP20)
Varian Medical Systems, Inc.
Flexible Fixation Device for Gynecological Applicators (GM11001960)
Varian Medical Systems, Inc.
Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)
Varian Medical Systems, Inc.
Universal Endometrial Applicator Set (GM11009840)
Varian Medical Systems, Inc.
Kelowna GYN and Crook Prostate Templates
Varian Medical Systems, Inc.
TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)
Varian Medical Systems, Inc.
Halcyon, Ethos Radiotherapy System
Varian Medical Systems, Inc.
ProBeam 360° Proton Therapy System v2.0 (Multiroom)
Varian Medical Systems, Inc.
TrueBeam, TrueBeam STx, Edge, VitalBeam
Varian Medical Systems, Inc.
IDENTIFY
Varian Medical Systems, Inc.
Eclipse Treatment Planning System (v18.0)
Varian Medical Systems, Inc.
TrueBeam, TrueBeam STx, Edge, VitalBeam
Varian Medical Systems, Inc.
ARIA Radiation Therapy Management (v18.0)
Varian Medical Systems, Inc.
ISOLIS Cryoprobe
Varian Medical Systems, Inc.
Aarhus Applicator Set
Varian Medical Systems, Inc.
Halcyon, Ethos Radiotherapy System
Varian Medical Systems, Inc.
ProBeam 360° Proton Therapy System
Varian Medical Systems, Inc.
TrueBeam, TrueBeam STx, Edge, VitalBeam
Varian Medical Systems, Inc.
Respiratory Gating For Scanners V2.0
Varian Medical Systems, Inc.
Urethral Warming Catheter Kit
Varian Medical Systems, Inc.
AI Segmentation
Varian Medical Systems, Inc.
Ethos Treatment Management, Ethos Treatment Planning
Varian Medical Systems, Inc.
AI Segmentation
Varian Medical Systems, Inc.
4D Integrated Treatment Console
Varian Medical Systems, Inc.
Mobius3D
Varian Medical Systems, Inc.
Universal Cylinder Applicator Family
Varian Medical Systems, Inc.
CRYOCARE TOUCH System And Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice
Varian Medical Systems, Inc.
GUDID#
Mandrin for 200 mm length - GM11010450
2024-02-16
Universal fixation button, radiopaque, pack of 100, non-sterile - GM11003800
2016-09-23
Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrin - GM11014710
2024-02-16
Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrin - GM11014720
2024-02-16
Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrin - GM11014730
2024-02-16
Mandrin for 320 mm length - GM11010470
2024-02-16
Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin - GM11014700
2024-02-16
Mandrin for 113 mm length - GM11010390
2024-02-16
Mandrin for 200mm length Needle for Plastic Interstitial Needle - GM11003270
2021-02-02
Flexible probe, 2.8 mm diameter x 320 mm - GM11002280
2016-09-22
Mould probe, ø 1.8 diameter x 320 mm, with mandrin - GM11002290
2016-09-19
Mandrin for 320mm length - GM11003100
2016-09-23
Mandrin for 113mm length Needle - GM11003340
2016-09-22
Catheter flap 200 mm x 290 mm x 10 mm, 40 channels - GM11003910
2016-09-23
Plastic needle, 2.0 mm diameter, 113 mm length with mandrin for 113 mm needles - GM11007560
2016-09-22
Plastic needle 2.0 mm diameter, 200 mm length with mandrin for 200 mm needles - For GM11003270
2016-09-18
Plastic needle ø 2.0 mm diameter, 320 mm length with mandrin for 320 mm needles - For GM11003100
2016-09-19
Plastic needle 2.0 mm diameter, 320 mm length, blunt tip w/ mandrin - for 320 mm needles(GM11003100)
2016-09-22
Velocity - 4.3
2026-07-16
Cleaning Cap, dark blue (pack of 25) - GM11010770
2016-09-22
SynchroWave ST Antenna - Short Tip Microwave Antenna Kit (15 cm, 1 per Tray)
2022-02-18
SynchroWave ST Antenna - Short Tip Microwave Antenna Kit (20 cm, 1 per Tray)
2022-02-18
2.4mm V-Probe™ Cryoprobe Right Angle - Variable ice right angle cryoprobe for use with Cryocare systems (Lead-Free)
2022-02-18
1.7 mm RenalCryo™ Cryoprobe - Right angle 1.7mm cryoprobe, oblong ice, for use with Cryocare systems
2022-02-18
1.7 mm RenalCryo™ Cryoprobe - Right angle 1.7mm cryoprobe, oblong ice. for use with Cryocare systems (Lead-Free)
2022-02-18
1.7 mm Long Shaft RenalCryo™ Cryoprobe - Right angle 1.7mm cryoprobe, oblong ice, long shaft, for use with Cryocare systems
2022-02-18
1.7 mm Long Shaft RenalCryo™ Cryoprobe - Right angle 1.7mm cryoprobe, long shaft, for use with Cryocare systems (Lead-Free)
2022-02-18
2.4mm RenalCryo™ Cryoprobe - Right angle 2.4m cryoprobe, oblong ice, for use with Cryocare systems
2022-02-18
2.4mm Long Shaft RenalCryo™ Cryoprobe - Right angle 2.4mm cryoprobe, oblong ice, long shaft, for use with Cryocare systems
2022-02-18
3.8 mm RenalCryo™ Cryoprobe - Right angle 3.8mm cryoprobe, oblong ice, for use with Cryocare systems
2022-02-18
3.8 mm RenalCryo™ Cryoprobe - Right angle 3.8mm cryoprobe, oblong ice, for use with Cryocare systems (Lead-Free)
2022-02-18
3.8 mm Long Shaft RenalCryo™ Cryoprobe - Right angle 3.8mm cryoprobe, oblong ice, long shaft, for use with Cryocare systems
2022-02-18
3.8 mm Long Shaft RenalCryo™ Cryoprobe - Right angle 3.8mm cryoprobe, long shaft, for use with Cryocare systems (Lead-Free)
2022-02-18
TempProbe™ Device - Temperature probe
2022-02-18
Prostate Procedure Probe Pack - Prostate Procedure Kit containing CVA2400 (4ea), CRYO-55-F (6 ea), CRYO-77 ( 1 ea)
2022-02-18
Prostate Procedure Probe Pack - Prostate Procedure Kit containing CVA2400 (6ea), CRYO-55-F (6 ea), CRYO-77 ( 1 ea)
2022-02-18
8mm Cryoprobe - Straight 8mm cryoprobefor use with Cryocare systems (Lead-Free)
2022-02-18
2.4mm V-Probe™ Cryoprobe - Variable ice cryoprobe for use with Cryocare systems
2022-02-18
2.4mm V-Probe™ Cryoprobe - Variable ice cryoprobe for use with Cryocare systems (Lead-Free)
2022-02-18
Interstitial ovoid pair for 30mm spread, with fixation for guide tubes - GM11013450
2025-05-21