Varian Medical Systems
Varian Medical Systems holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2026, with 2 FDA device recalls on record.
Top product codes for Varian Medical Systems
FDA recalls by Varian Medical Systems
- Z-0005-2019 — 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 conditions anywhere in the body where radiation treatment is indicated.
- Z-0004-2019 — 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 stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
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
- K261306 — AI Contouring (VA10A)
- K252717 — MAASTRO Rectal Applicator Set
- K252884 — Guided Aarhus Applicator Set
- K250099 — Mobius3D (4.1)
- K250289 — Intracavitary/Interstitial System
- K242378 — Eclipse Treatment Planning System (18.1)
- K242961 — Intraluminal Applicator Set
- K241965 — Catheter Surface Flap Applicator Set (GM11011830)
- K241876 — Vitesse (5.0)
- K232400 — VariSeed (v10)
- K133191 — PROBEAM PROTON THERAPY SYSTEM
- K124002 — VERIFICATION CONSOLE
- K123137 — CALYPSO SYSTEM
- K112778 — SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING
- K112839 — VARIAN HIGH ENERGY LINEAR ACCELERATOR
- K102024 — RPM RESPIRATORY GATING SYSTEM
- K100890 — VARIAN HIGH ENERGY LINEAR ACCELERATOR
- K093250 — PROTON THERAPY MULTILEAF COLLIMATOR
- K091132 — 4D INTEGRATED TREATMENT CONSOLE
- K071992 — HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)
- K071381 — GAMMAMEDPLUS IX SERIES HDR AFTERLOADER
- K063815 — VARIAN ESOPHAGUS BOUGIE APPLICATOR
- K061140 — TRILOGY RADIOTHERAPY DELIVERY SYSTEM
- K052391 — VISION (WITH OFF-LINE REVIEW)
- K050296 — ECLIPSE TREATMENT PLANNING SYSTEM
- K050479 — 4D INTEGRATED TREATMENT CONSOLE
- K050442 — MILLENNIUM MULTI-LEAF COLLIMATOR
- K042720 — ON-BOARD IMAGER DEVICE
- K041403 — ECLIPSE WITH AAA
- K033371 — VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS
- K030534 — VARISEED 7.1
- K030745 — GAMMAMED 212 AND 232 SOURCE ASSEMBLY
- K023220 — VARISOURCE BREAST TEMPLATE SYSTEM
- K012017 — VARISEED 7.0
Data sourced from openFDA. This site is unofficial and independent of the FDA.