Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unirad Corp. — 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) |
|---|---|---|---|---|---|
| K801656 | EDP 1200 SECTOR SCANNER OPTION | Unirad Corp. | 1980-09-26 | 67 | 0 |
| K801655 | AUTO SECTOR SCANNER | Unirad Corp. | 1980-09-26 | 67 | 0 |
| K792638 | HIGH RESOLUTION IMAGING SYSTEM | Unirad Corp. | 1980-01-28 | 39 | 0 |
| K770644 | ULTRASOUND B-SCANNING SYSTEM | Unirad Corp. | 1977-04-14 | 10 | 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