Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Varian Medical Systems, X-Ray Products-Infimed · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161459 | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv | Varian Medical Systems, X-Ray Products-Infimed | 2016-09-06 | 103 | 0 |
| K130318 | NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) | Varian Medical Systems, X-Ray Products-Infimed | 2013-04-22 | 73 | 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