Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Almana Medical Imaging · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
172 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100001 | MOBIVISION | Almana Medical Imaging | 2010-06-25 | 172 | 0 |
| K082064 | RADVISION ET DIAGNOSTIC X-RAY SYSTEM | Almana Medical Imaging | 2008-08-22 | 32 | 0 |
| K080847 | RFVISION, MODEL 9.9D | Almana Medical Imaging | 2008-08-06 | 133 | 0 |
| K080614 | DR VISION NEO, DR VISION DOU | Almana Medical Imaging | 2008-06-20 | 107 | 0 |
| K072659 | RAD VISION, MODELS E AND EU | Almana Medical Imaging | 2007-11-15 | 56 | 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