Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medivision Medical Imaging, Ltd. — 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) |
|---|---|---|---|---|---|
| K062295 | IRI INTEGRATED RETINAL IMAGER | Medivision Medical Imaging, Ltd. | 2006-10-20 | 74 | 0 |
| K953974 | CAMVISION 1000 | Medivision Medical Imaging, Ltd. | 1996-09-09 | 383 | 0 |
| K953973 | ANGIOVISION 1000 | Medivision Medical Imaging, Ltd. | 1995-11-17 | 86 | 0 |
| K953972 | ANGIOVISION VIEWING STATION | Medivision Medical Imaging, Ltd. | 1995-11-17 | 86 | 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