Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Xerox Medical Systems · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
95 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853459 | XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM | Xerox Medical Systems | 1985-10-30 | 75 | 0 |
| K833243 | MAMMOGRAPHIC S-RAY SYSTEM | Xerox Medical Systems | 1983-10-28 | 71 | 0 |
| K832733 | XEROX 120 SYS MAMMOGRAPHIC X-RAY | Xerox Medical Systems | 1983-09-29 | 41 | 0 |
| K812024 | XEROX 128 CASSETTE CHANGER | Xerox Medical Systems | 1981-08-13 | 24 | 0 |
| K791014 | DENTAL XERORADIOGRAPHY | Xerox Medical Systems | 1979-09-04 | 95 | 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