Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mitra Imaging, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982769 | MITRA IMAGING INC. EXHIBIT | Mitra Imaging, Inc. | 1998-11-03 | 88 | 1 |
| K974102 | MILTRA IMAGING INC., IMAGE VAULT | Mitra Imaging, Inc. | 1998-01-20 | 81 | 0 |
| K970652 | MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE | Mitra Imaging, Inc. | 1997-05-02 | 70 | 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