Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
X-Ray 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) |
|---|---|---|---|---|---|
| K884493 | HEAD HOLDING DEVICE/SLEEP APNEA | X-Ray Systems | 1989-01-12 | 78 | 0 |
| K855161 | UPRIGHT BUCKY STAND/MOUNT | X-Ray Systems | 1986-02-12 | 48 | 0 |
| K855052 | TABLE RADIOGRAPHIC FIXED | X-Ray Systems | 1986-02-06 | 51 | 0 |
| K853682 | MOUNT TUBE RADIOGRAPHIC | X-Ray Systems | 1985-09-19 | 15 | 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