Company · US
Varian Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2026. Name variants (Inc, Corp, punctuation) are merged.
206510(k) clearances (10 in 12 months)
63recalls (0 in 12 months)
56recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IYE | Accelerator, Linear, Medical | 110 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 85 |
| MUJ | System, Planning, Radiation Therapy Treatment | 40 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 8 |
| KPQ | System, Simulation, Radiation Therapy | 5 |
| JAK | System, X-Ray, Tomography, Computed | 4 |
| KXK | Source, Brachytherapy, Radionuclide | 4 |
| GEH | Unit, Cryosurgical, Accessories | 3 |
| KRD | Device, Vascular, For Promoting Embolization | 2 |
| NEY | System, Ablation, Microwave And Accessories | 2 |
| IWB | System, Radiation Therapy, Radionuclide | 1 |
| KPR | System, X-Ray, Stationary | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 1 |
| QKB | Radiological Image Processing Software For Radiation Therapy | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 3, 2026 | K261856 | Halcyon, Ethos Radiotherapy System (5.0) Varian Medical Systems, Inc. | IYE |
| Jul 10, 2026 | K261306 | AI Contouring (VA10A) Varian Medical Systems | QKB |
| Jul 8, 2026 | K260750 | Virtual Cone (1.0) Varian Medical Systems, Inc. | MUJ |
| Jun 4, 2026 | K253026 | Respiratory Gating for Scanners (2.1) Varian Medical Systems, Inc. | JAK |
| May 20, 2026 | K252717 | MAASTRO Rectal Applicator Set Varian Medical Systems | JAQ |
| Apr 23, 2026 | K252815 | ProBeam 360 Proton Therapy System v3.0 Varian Medical Systems, Inc. | LHN |
| Mar 18, 2026 | K252304 | syngo.via RT Image Suite VC10 Varian Medical Systems, Inc. | MUJ |
| Jan 21, 2026 | K252977 | Halcyon, Ethos Radiotherapy System (5.0) Varian Medical Systems, Inc. | IYE |
| Dec 16, 2025 | K252919 | IDENTIFY (5.0) Varian Medical Systems, Inc. | IYE |
| Nov 19, 2025 | K252884 | Guided Aarhus Applicator Set Varian Medical Systems | JAQ |
| Oct 7, 2025 | K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeam Varian Medical Systems, Inc. | IYE |
| May 16, 2025 | K250099 | Mobius3D (4.1) Varian Medical Systems | IYE |
| May 9, 2025 | K250299 | CT/ MR Tandem and Ovoid Set Varian Medical Systems, Inc. | JAQ |
| Apr 25, 2025 | K250289 | Intracavitary/Interstitial System Varian Medical Systems | JAQ |
| Mar 3, 2025 | K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) Varian Medical Systems, Inc. | JAQ |
| Feb 7, 2025 | K242957 | Identify (4.0) Varian Medical Systems, Inc. | IYE |
| Jan 17, 2025 | K242608 | Embozene Color-Advanced Microspheres Varian Medical Systems, Inc. | KRD |
| Jan 10, 2025 | K241764 | Mould Probe MR Safe Varian Medical Systems, Inc. | JAQ |
| Dec 13, 2024 | K242463 | ARIA Radiation Therapy Management System (18.1) Varian Medical Systems, Inc. | MUJ |
| Dec 11, 2024 | K242378 | Eclipse Treatment Planning System (18.1) Varian Medical Systems | MUJ |
| Nov 26, 2024 | K242961 | Intraluminal Applicator Set Varian Medical Systems | JAQ |
| Nov 21, 2024 | K242874 | Gating Reflector Block Varian Medical Systems, Inc. | JAK |
| Nov 7, 2024 | K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve Varian Medical Systems, Inc. | JAQ |
| Oct 29, 2024 | K241965 | Catheter Surface Flap Applicator Set (GM11011830) Varian Medical Systems | JAQ |
| Oct 23, 2024 | K241876 | Vitesse (5.0) Varian Medical Systems | MUJ |
| Oct 16, 2024 | K242794 | ONCOZENE Microspheres Varian Medical Systems, Inc. | KRD |
| Aug 30, 2024 | K241386 | Heyman Packing Applicator Set (GM11004580) Varian Medical Systems, Inc. | JAQ |
| Jul 19, 2024 | K240480 | IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); I Varian Medical Systems, Inc. | NEY |
| May 29, 2024 | K240784 | Temperature Sensor Probe (ABL-18TP20) Varian Medical Systems, Inc. | NEY |
| May 9, 2024 | K240495 | Flexible Fixation Device for Gynecological Applicators (GM11001960) Varian Medical Systems, Inc. | JAQ |
| Apr 30, 2024 | K232923 | Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) Varian Medical Systems, Inc. | IYE |
| Apr 9, 2024 | K232623 | Universal Endometrial Applicator Set (GM11009840) Varian Medical Systems, Inc. | JAQ |
| Feb 1, 2024 | K232949 | Kelowna GYN and Crook Prostate Templates Varian Medical Systems, Inc. | JAQ |
| Dec 21, 2023 | K232870 | TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) Varian Medical Systems, Inc. | IYE |
| Nov 3, 2023 | K232113 | Halcyon, Ethos Radiotherapy System Varian Medical Systems, Inc. | IYE |
| Oct 6, 2023 | K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) Varian Medical Systems, Inc. | LHN |
| Sep 12, 2023 | K231317 | TrueBeam, TrueBeam STx, Edge, VitalBeam Varian Medical Systems, Inc. | IYE |
| Sep 8, 2023 | K232400 | VariSeed (v10) Varian Medical Systems | MUJ |
| Jul 25, 2023 | K230576 | IDENTIFY Varian Medical Systems, Inc. | IYE |
| May 26, 2023 | K230557 | Eclipse Treatment Planning System (v18.0) Varian Medical Systems, Inc. | MUJ |
| May 22, 2023 | K223839 | TrueBeam, TrueBeam STx, Edge, VitalBeam Varian Medical Systems, Inc. | IYE |
| Apr 10, 2023 | K230699 | ARIA Radiation Therapy Management (v18.0) Varian Medical Systems, Inc. | IYE |
| Mar 28, 2023 | K230271 | ISOLIS Cryoprobe Varian Medical Systems, Inc. | GEH |
| Mar 13, 2023 | K222775 | Aarhus Applicator Set Varian Medical Systems, Inc. | JAQ |
| Jan 17, 2023 | K222941 | Halcyon, Ethos Radiotherapy System Varian Medical Systems, Inc. | IYE |
| Dec 1, 2022 | K221791 | ProBeam 360° Proton Therapy System Varian Medical Systems, Inc. | LHN |
| Sep 14, 2022 | K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device Varian Medical Systems, Inc. | JAQ |
| Jun 17, 2022 | K221408 | ARIA Radiation Therapy Management (v16.1 MR3) Varian Medical Systems, Inc. | IYE |
| Jun 15, 2022 | K221448 | ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) Varian Medical Systems, Inc. | IYE |
| Jun 3, 2022 | K213977 | TrueBeam, TrueBeam STx, Edge, VitalBeam Varian Medical Systems, Inc. | IYE |
Newest 50 of 206.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2019 | Varian Medical Systems, Inc. Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - P Terminated |
IYE | K181404 |
| Dec 26, 2018 | Varian Medical Systems, Inc. Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only
The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for pati Terminated |
MUJ | K170969 K172163 +1 |
| Aug 20, 2018 | Varian Medical Systems VitalBeam Radiotherapy Delivery System Version 2.5
Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and Terminated |
IYE | K150706 |
| Aug 20, 2018 | Varian Medical Systems TrueBeam Radiotherapy Delivery System version 2.0 and 2.5
EDGE Radiotherapy Delivery System version 2.0 and 2.5
Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and Terminated |
IYE | K140528 K143224 |
| Jan 10, 2017 | Varian Medical Systems, Inc. Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12]
Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is Terminated |
IYE | K141283 |
| Oct 13, 2016 | Varian Medical Systems, Inc. Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016).
The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for t Terminated |
IYE | K142560 |
| Jul 11, 2016 | Varian Medical Systems, Inc. Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE;
Radiology: The AlignRT Plus system is indicated for use to position
and monitor patients relative to the presc Terminated |
IYE | K123371 |
| Jul 11, 2016 | Varian Medical Systems, Inc. Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE;
Radiology: The AlignRT Plus system is indicated for use to position
and monitor patients relative Terminated |
IYE | K123371 |
| Feb 12, 2016 | Varian Medical Systems, Inc. Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6;
Model number: H48;
Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for Terminated |
MUJ | K152393 |
| Oct 30, 2015 | Varian Medical Systems, Inc. ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License.
Model number HIT
Product Usage:
ARIA Radiation Oncology is a radiation treatment plan and image managemen Terminated |
MUJ | K093527 |
| Jun 26, 2015 | Varian Medical Systems Inc The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internall Terminated |
JAQ | K122236 |
| Jun 23, 2015 | Varian Medical Systems Inc Surface Applicator Set with Leipzig-style Cone.
Brachytherapy applicator set. Terminated |
JAQ | K123815 |
| Dec 16, 2014 | Varian Medical Systems, Inc. Varian On-Board Imager Advanced Imaging System.
The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in re Terminated |
IYE | K042720 |
| Sep 16, 2014 | Varian Medical Systems, Inc. 4D Integrated Treatment Console (4DITC), versions 10 and 11.
4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation thera Terminated |
MUJ | K133331 |
| Sep 13, 2014 | Varian Medical Systems, Inc. C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and Terminated |
IYE | None listed |
| Apr 24, 2014 | Varian Medical Systems, Inc. On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors.
Product Usage:
The On-Board Imager device is an x-ray device used for evaluation of correct patient po Terminated |
IYE | K042720 |
| Dec 20, 2013 | Varian Medical Systems, Inc. Plan Parameters workspace within
Eclipse Treatment Planning System Version 11 and 13;
ARIA Radiation Oncology versions 11 and 13
Acuity, versions 11 and 13.
Manufactured by Varian Medical Systems
Pal Terminated |
MUJ | K093527 K131807 |
| Dec 3, 2013 | Varian Medical Systems, Inc. C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US.
Product Usage: T Terminated |
IYE | K131807 K132705 |
| Oct 24, 2013 | Varian Medical Systems, Inc. VARISOURCE Breast Template System for high-dose rate Brachytherapy.
***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen W Terminated |
JAQ | K023220 |
| May 15, 2013 | Varian Medical Systems, Inc. Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR)
Product Usage: Usage:
Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer. Terminated |
JAQ | None listed |
| Jan 31, 2013 | Varian Medical Systems, Inc. Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. Terminated |
JAQ | K011657 |
| Jan 31, 2013 | Varian Medical Systems, Inc. Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. Terminated |
JAQ | K011657 |
| Dec 20, 2012 | Varian Medical Systems, Inc. Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves
The guide tube for segments and cervical sleeves in the Segmented Cervix Appl Terminated |
JAQ | K983436 |
| Apr 10, 2012 | Varian Medical Systems, Inc. VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy pr Terminated |
KXK | K030534 |
| Mar 12, 2012 | Varian Medical Systems, Inc. Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used with the VariSource" IX HDR Afterloader.
Product Usage: The adapter is part of the VariSour Terminated |
JAQ | K071467 |
| Mar 12, 2012 | Varian Medical Systems, Inc. Nucletron Adapter and Transfer Guide Tube, part number AL 13005000, a component used with the VariSource" IX HDR Afterloader.
Product Usage: The adapter is part of the VariSource Afterloader System, Terminated |
JAQ | K071467 |
| Dec 1, 2011 | Varian Medical Systems, Inc. VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader.
The VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electra/mechanical sy Terminated |
JAQ | K071467 |
| Dec 1, 2011 | Varian Medical Systems, Inc. GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germ Terminated |
JAQ | K983436 |
| Dec 1, 2011 | Varian Medical Systems, Inc. GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 200 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germ Terminated |
JAQ | K983436 |
| Dec 1, 2011 | Varian Medical Systems, Inc. GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 113 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germ Terminated |
JAQ | K983436 |
| Nov 30, 2011 | Varian Medical Systems, Inc. GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan GmbH.
Designed for brachytherapy intra Terminated |
JAQ | K983436 |
| Nov 23, 2011 | Varian Medical Systems, Inc. Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the Segmented Cylinder Set, GM11004150) Terminated |
JAQ | K033371 |
| Sep 14, 2011 | Varian Medical Systems, Inc. Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a component of the Clinac, All Varian Clinac using the collimator cover P/N 1106900-xx, Model Numbers:
H14, H18, H27, H Terminated |
IYE | K100890 |
| Aug 31, 2011 | Varian Medical Systems, Inc. BrachyVision, versions 8.2, 8.5, 8.6 and 8.9.
Varian Medical Systems.
3100 Hansen Way,
Palo Alto, California 94304-1038.
Used to plan radiotherapy treatments for patients with malignant or benign d Terminated |
MUJ | K091492 |
| Dec 28, 2010 | Varian Medical Systems Inc. Varian brand Trilogy System with RapidArc, Model Numbers:
H14, H26, H27, H29; Distributed and Manufactured by:
Varian Medical Systems Inc., Palo Alto, CA Terminated |
IYE | K072916 |
| Sep 16, 2008 | Varian Medical Systems, Inc. VariSource CT/MR Ring & Tandem Applicator Set, catalog # AL13017000, containing 32mm titanium ring applicators, each identified as part numbers AL07362000, AL07363000, and AL07364000. Terminated |
JAQ | K030110 |
| Feb 15, 2008 | Varian Medical Systems Inc Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models; Varian Medical Systems, Palo Terminated |
IYE | K001643 |
| Feb 14, 2008 | Varian Medical Systems Inc Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system;
Model: Low Energy Clinacs with one or more of the following options:
-- BrainLAB micro MLC
-- Stereotacti Terminated |
IYE | K070094 |
| Feb 14, 2008 | Varian Medical Systems Inc Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system: Model: High Energy Clinacs with one or more of the following options:
-- BrainLAB micro MLC,
-- 6MV SRS ph Terminated |
IYE | K070094 |
| Jan 29, 2008 | Varian Medical Systems Inc Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medical Systems, Palo Alto, CA 94304 Terminated |
IYE | K063270 |
| Nov 8, 2007 | Varian Medical Systems Inc Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems Terminated |
KPQ | K851653 |
| Aug 29, 2007 | Varian Medical Systems Inc Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator. Terminated |
IYE | K040192 K041519 +1 |
| Jul 12, 2007 | Varian Medical Systems Inc Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C/D, Clinac 2100 C, C/D & EX and Clinac 2300 C &C/D Terminated |
IYE | K862645 K913119 |
| Jun 28, 2007 | Varian Medical Systems Inc LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1. Terminated |
IYE | None listed |
| Jan 11, 2007 | Varian Medical Systems GammaMed 12it radionuclide applicator system, Varian Medical Systems, Palo Alto, CA. Terminated |
JAQ | None listed |
| Jan 11, 2007 | Varian Medical Systems GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA Terminated |
JAQ | K891131 K912555 |
| Dec 19, 2006 | Varian Medical Systems Inc 4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy System;
All 4D Integrated treatment console versions 8.0.15 and below (excluding v7.0.31) and all Varis Non-V Terminated |
IYE | K001643 K050479 |
| Nov 16, 2006 | Varian Medical Systems Inc Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C,C/D EX) and 2300 C, C/D EX) Terminated |
IYE | K904264 K913119 |
| Aug 10, 2006 | Varian Medical Systems GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number GM11005400, for the GammaMed model 12it radionuclide applicator system. Terminated |
JAQ | K912555 |
| Aug 10, 2006 | Varian Medical Systems GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number GM11005400, for the GammaMed model 12i radionuclide applicator system. Terminated |
JAQ | K891131 |
Newest 50 of 63.