Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Varian Medical Systems · Predicate Candidate Screening
34 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
122 days90th percentile
34clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261306 | AI Contouring (VA10A) | Varian Medical Systems | 2026-07-10 | 81 | 0 |
| K252717 | MAASTRO Rectal Applicator Set | Varian Medical Systems | 2026-05-20 | 265 | 0 |
| K252884 | Guided Aarhus Applicator Set | Varian Medical Systems | 2025-11-19 | 70 | 0 |
| K250099 | Mobius3D (4.1) | Varian Medical Systems | 2025-05-16 | 122 | 0 |
| K250289 | Intracavitary/Interstitial System | Varian Medical Systems | 2025-04-25 | 84 | 0 |
| K242378 | Eclipse Treatment Planning System (18.1) | Varian Medical Systems | 2024-12-11 | 124 | 0 |
| K242961 | Intraluminal Applicator Set | Varian Medical Systems | 2024-11-26 | 62 | 0 |
| K241965 | Catheter Surface Flap Applicator Set (GM11011830) | Varian Medical Systems | 2024-10-29 | 118 | 0 |
| K241876 | Vitesse (5.0) | Varian Medical Systems | 2024-10-23 | 117 | 0 |
| K232400 | VariSeed (v10) | Varian Medical Systems | 2023-09-08 | 29 | 0 |
| K133191 | PROBEAM PROTON THERAPY SYSTEM | Varian Medical Systems | 2014-01-10 | 85 | 1 |
| K124002 | VERIFICATION CONSOLE | Varian Medical Systems | 2013-02-21 | 57 | 0 |
| K123137 | CALYPSO SYSTEM | Varian Medical Systems | 2012-12-05 | 61 | 0 |
| K112778 | SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING | Varian Medical Systems | 2011-12-29 | 94 | 0 |
| K112839 | VARIAN HIGH ENERGY LINEAR ACCELERATOR | Varian Medical Systems | 2011-11-14 | 47 | 1 |
| K102024 | RPM RESPIRATORY GATING SYSTEM | Varian Medical Systems | 2010-10-15 | 88 | 1 |
| K100890 | VARIAN HIGH ENERGY LINEAR ACCELERATOR | Varian Medical Systems | 2010-07-13 | 104 | 10 |
| K093250 | PROTON THERAPY MULTILEAF COLLIMATOR | Varian Medical Systems | 2009-12-24 | 69 | 0 |
| K091132 | 4D INTEGRATED TREATMENT CONSOLE | Varian Medical Systems | 2009-06-17 | 58 | 5 |
| K071992 | HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) | Varian Medical Systems | 2007-08-15 | 26 | 4 |
| K071381 | GAMMAMEDPLUS IX SERIES HDR AFTERLOADER | Varian Medical Systems | 2007-07-18 | 62 | 0 |
| K063815 | VARIAN ESOPHAGUS BOUGIE APPLICATOR | Varian Medical Systems | 2007-03-01 | 69 | 0 |
| K061140 | TRILOGY RADIOTHERAPY DELIVERY SYSTEM | Varian Medical Systems | 2006-05-15 | 21 | 0 |
| K052391 | VISION (WITH OFF-LINE REVIEW) | Varian Medical Systems | 2005-11-23 | 84 | 0 |
| K050296 | ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems | 2005-11-03 | 269 | 0 |
| K050479 | 4D INTEGRATED TREATMENT CONSOLE | Varian Medical Systems | 2005-03-24 | 28 | 2 |
| K050442 | MILLENNIUM MULTI-LEAF COLLIMATOR | Varian Medical Systems | 2005-03-23 | 29 | 2 |
| K042720 | ON-BOARD IMAGER DEVICE | Varian Medical Systems | 2004-10-29 | 28 | 5 |
| K041403 | ECLIPSE WITH AAA | Varian Medical Systems | 2004-07-26 | 61 | 0 |
| K033371 | VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS | Varian Medical Systems | 2003-12-24 | 64 | 2 |
| K030534 | VARISEED 7.1 | Varian Medical Systems | 2003-05-21 | 90 | 1 |
| K030745 | GAMMAMED 212 AND 232 SOURCE ASSEMBLY | Varian Medical Systems | 2003-03-12 | 2 | 0 |
| K023220 | VARISOURCE BREAST TEMPLATE SYSTEM | Varian Medical Systems | 2002-10-25 | 28 | 1 |
| K012017 | VARISEED 7.0 | Varian Medical Systems | 2001-07-12 | 14 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda