Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Interad Systems, 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) |
|---|---|---|---|---|---|
| K834087 | MODEL XLE | Interad Systems, Inc. | 1984-02-27 | 166 | 0 |
| K834307 | ULTRASOUND SCANNER XL | Interad Systems, Inc. | 1984-02-21 | 110 | 0 |
| K833821 | INTERAD 520 | Interad Systems, Inc. | 1984-01-13 | 72 | 0 |
| K813162 | INTERAD WHOLE BODY CT SCANNER | Interad Systems, Inc. | 1981-12-14 | 34 | 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