Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Varian Medical Systems, Oncology Systems · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123152 | VITESSE 3.0 | Varian Medical Systems, Oncology Systems | 2012-12-07 | 59 | 0 |
| K103394 | BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV) | Varian Medical Systems, Oncology Systems | 2011-01-12 | 54 | 1 |
| K101294 | PT2 VARIAN PROTON THERAPY SYSTEM | Varian Medical Systems, Oncology Systems | 2010-12-27 | 231 | 0 |
| K101751 | VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR | Varian Medical Systems, Oncology Systems | 2010-08-10 | 49 | 1 |
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