Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Image Diagnostics, 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) |
|---|---|---|---|---|---|
| K950631 | ID400 SERIES ARMBOARDS | Image Diagnostics, Inc. | 1995-03-24 | 39 | 0 |
| K944772 | MULTIPLE ED1600 SERIES RADIATION SHIELDS | Image Diagnostics, Inc. | 1994-10-20 | 23 | 0 |
| K942190 | ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE | Image Diagnostics, Inc. | 1994-08-17 | 105 | 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