Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Radiological Engineering, Inc. — 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) |
|---|---|---|---|---|---|
| K873702 | REI-38 RADIOGRAPHIC TABLE | Radiological Engineering, Inc. | 1988-04-22 | 221 | 0 |
| K854478 | REI-90/90 RADIOGRAPHIC TABLE | Radiological Engineering, Inc. | 1986-04-17 | 161 | 0 |
| K853210 | MST-1050-II X-RAY UNIT | Radiological Engineering, Inc. | 1985-10-10 | 71 | 0 |
| K853175 | REI-90/15 | Radiological Engineering, Inc. | 1985-10-10 | 72 | 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