Varian Medical Systems, Inc.
Varian Medical Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1997, most recent 2026, with 21 FDA device recalls on record.
Top product codes for Varian Medical Systems, Inc.
FDA recalls by Varian Medical Systems, Inc.
10 most recent of 21- Z-1899-2020 — 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 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.
- Z-0771-2019 — 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 patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, elec- tron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
- Z-0990-2017 — 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 used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments.
- Z-0077-2017 — 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 treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
- Z-2150-2016 — 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 prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
- Z-2149-2016 — 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 to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
- Z-0805-2016 — 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 patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments.
- Z-0170-2016 — 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 management application.
- Z-1829-2015 — Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
- Z-1849-2015 — 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 internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Varian Medical Systems, Inc.
1–100 of 172- K261856 — Halcyon, Ethos Radiotherapy System (5.0)
- K260750 — Virtual Cone (1.0)
- K253026 — Respiratory Gating for Scanners (2.1)
- K252815 — ProBeam 360 Proton Therapy System v3.0
- K252304 — syngo.via RT Image Suite VC10
- K252977 — Halcyon, Ethos Radiotherapy System (5.0)
- K252919 — IDENTIFY (5.0)
- K252948 — TrueBeam, TrueBeam STX, Edge and VitalBeam
- K250299 — CT/ MR Tandem and Ovoid Set
- K243939 — Titanium Flexible Geometry FSD Applicator Set (GM11013400)
- K242957 — Identify (4.0)
- K242608 — Embozene Color-Advanced Microspheres
- K241764 — Mould Probe MR Safe
- K242463 — ARIA Radiation Therapy Management System (18.1)
- K242874 — Gating Reflector Block
- K241853 — Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve
- K242794 — ONCOZENE Microspheres
- K241386 — Heyman Packing Applicator Set (GM11004580)
- K240480 — IntelliBlate Microwave Ablation System Console (IB-CON) +4 more
- K240784 — Temperature Sensor Probe (ABL-18TP20)
- K240495 — Flexible Fixation Device for Gynecological Applicators (GM11001960)
- K232923 — Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)
- K232623 — Universal Endometrial Applicator Set (GM11009840)
- K232949 — Kelowna GYN and Crook Prostate Templates
- K232870 — TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)
- K232113 — Halcyon, Ethos Radiotherapy System
- K231863 — ProBeam 360° Proton Therapy System v2.0 (Multiroom)
- K231317 — TrueBeam, TrueBeam STx, Edge, VitalBeam
- K230576 — IDENTIFY
- K230557 — Eclipse Treatment Planning System (v18.0)
- K223839 — TrueBeam, TrueBeam STx, Edge, VitalBeam
- K230699 — ARIA Radiation Therapy Management (v18.0)
- K230271 — ISOLIS Cryoprobe
- K222775 — Aarhus Applicator Set
- K222941 — Halcyon, Ethos Radiotherapy System
- K221791 — ProBeam 360° Proton Therapy System
- K221797 — BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device
- K221408 — ARIA Radiation Therapy Management (v16.1 MR3)
- K221448 — ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)
- K213977 — TrueBeam, TrueBeam STx, Edge, VitalBeam
- K213927 — Respiratory Gating for Scanners v2.0
- K211149 — Urethral Warming Catheter Kit
- K211881 — AI Segmentation
- K212294 — Ethos Treatment Management, Ethos Treatment Planning
- K210835 — Identify
- K203469 — AI Segmentation
- K203766 — 4D Integrated Treatment Console
- K203669 — Mobius3D
- K193240 — Universal Cylinder Applicator Family
- K201588 — CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice
- K201607 — Eclipse Treatment Planning System v16.1
- K200608 — Eclipse Treatment Planning System v16.0
- K192377 — Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
- K192968 — IDENTIFY
- K192424 — Mobius3D
- K191761 — Mobius3D
- K190137 — Identify
- K191580 — BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device
- K172533 — GM Implant Tubes, Length Cutting Gauge
- K181903 — BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device
- K181404 — Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator
- K181145 — Eclipse Treatment Planning System
- K172675 — Varian Cervical Sleeves
- K181032 — Halcyon
- K170570 — Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung
- K180586 — Varian Head Frame
- 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
- K173636 — Velocity
- K171631 — Standard Catheter Set
- K173838 — ARIA Radiation Therapy Management
- K162533 — Kelowna GYN and Crook Prostate Templates
- K172163 — Eclipse Treatment Planning System
- K172013 — VitalBeam
- K171733 — TrueBeam, TrueBeam STx, Edge
- K170969 — Eclipse Treatment Planning System
- K170817 — Halcyon
- K162615 — Mould Applicator Set
- K160815 — Interstitial Needles
- K162018 — Surface Applicator Set
- K162472 — TrueBeam-TrueBeam STx-Edge
- K162476 — Varian High Energy Linear Accelerator
- K160045 — Heyman Packing Applicator Set
- K161540 — Advanced Breast Template System
- K161576 — Esophagus Bougie Set
- 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
- K160021 — Varian Sterilization Boxes
- K151022 — Intraluminal Applicator Set
- K152761 — Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G)
- K151882 — Varian Treatment (VTx)
- K152393 — Eclipse Treatment Planning System
- K152018 — Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets
- K151533 — Respiratory Gating for Scanners
- K151657 — Shielded Applicator Set, Cervical Stop
- K150839 — 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90
- K150636 — VariSeed 9.0
- K150706 — VitalBeam
- K141624 — PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113
- K143224 — TrueBeam-TrueBeam STx-Edge
- K142560 — Varian Head Frame
- K142268 — Varian Verification System (VVS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.