# Varian Medical Systems, Inc.

- Location (FDA's records): Palo Alto, CA
- FDA decisions: 206 (1997–2026): 206 510(k) clearances
- Names in FDA's records: Varian Medical Systems, Inc. (172); Varian Medical Systems (34)
- Product codes: IYE (83), JAQ (59), MUJ (33), LHN (8), KPQ (4), JAK (4), GEH (3), KXK (3), NEY (2), KRD (2), KPR (1), LLZ (1)
- 510(k) review time since 2016: median 99 days, against 126 for FDA's reviews in the same codes and years (58 of 90 faster)
- Predicates its devices cite: 258 (168 its own); citations of its devices by later devices: 269 (168 its own)
- Recalls linked to its devices: 119 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Varian Assoc., Inc.: 19 (https://510kreport.com/company/varian-assoc)
- Gammamed USA: 13 (https://510kreport.com/company/gammamed-usa)
- Surgical Navigation Technologies, Inc.: 7 (https://510kreport.com/company/surgical-navigation-technologies)
- Calypso Medical Technologies, Inc.: 5 (https://510kreport.com/company/calypso-medical-technologies)
- Mick Radio-Nuclear Instruments, Inc.: 5 (https://510kreport.com/company/mick-radio-nuclear-instruments)
- Varian Medical Systems, Oncology Systems: 4 (https://510kreport.com/company/varian-medical-systems-oncology-systems)
- Nucletron Corp.: 3 (https://510kreport.com/company/nucletron)
- Covidien: 2 (https://510kreport.com/company/covidien)

## Firms that cite its devices most
- Prowess, Inc.: 5 (https://510kreport.com/company/prowess)
- Computerized Medical Systems, Inc.: 4 (https://510kreport.com/company/computerized-medical-systems)
- Manteia Technologies Co., Ltd.: 3 (https://510kreport.com/company/manteia-technologies)
- Isodose Control B.V.: 3 (https://510kreport.com/company/isodose-control)
- Viewray, Incorporated: 3 (https://510kreport.com/company/viewray)
- Elekta, Ltd.: 3 (https://510kreport.com/company/elekta)
- Siemens Medical Solutions USA, Inc.: 3 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Spencer Fillmore: 2 (https://510kreport.com/company/spencer-fillmore)

## Its most-cited devices
- K033371: Varian Intracavitary Brachytherapy Applicators (2003), cited by 8
- K983629: RPM Respiratory Gating System (1999), cited by 7
- K003636: Portalvision (2001), cited by 6
- K024147: Paxscan 4030 Medical Digital Imaging System (2003), cited by 6
- K072916: Trilogy System with Rapidarc (2007), cited by 6
- K102011: Eclipse Treatment Planning System (2010), cited by 5

## Recent decisions
- K261856: Halcyon, Ethos Radiotherapy System (5.0) (Aug 3, 2026)
- K261306: AI Contouring (VA10A) (Jul 10, 2026)
- K260750: Virtual Cone (1.0) (Jul 8, 2026)
- K253026: Respiratory Gating for Scanners (2.1) (Jun 4, 2026)
- K252717: MAASTRO Rectal Applicator Set (May 20, 2026)
- K252815: ProBeam 360 Proton Therapy System v3.0 (Apr 23, 2026)
- K252304: syngo.via RT Image Suite VC10 (Mar 18, 2026)
- K252977: Halcyon, Ethos Radiotherapy System (5.0) (Jan 21, 2026)

Source page: https://510kreport.com/company/varian-medical-systems