Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Omega Medical Imaging, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
230 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100102 | CS-SERIES-FP | Omega Medical Imaging, Inc. | 2010-08-31 | 230 | 0 |
| K093572 | R650 QDASM COLLIMATOR | Omega Medical Imaging, Inc. | 2010-02-03 | 77 | 0 |
| K070834 | CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIG | Omega Medical Imaging, Inc. | 2007-05-18 | 52 | 0 |
| K062647 | E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 | Omega Medical Imaging, Inc. | 2006-10-20 | 44 | 0 |
| K050092 | R605 FACS COLLIMETER | Omega Medical Imaging, Inc. | 2005-01-31 | 17 | 0 |
| K990055 | B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 | Omega Medical Imaging, Inc. | 1999-02-02 | 26 | 0 |
| K970947 | B-350 CEILING MOUNTED C-POSITIONER | Omega Medical Imaging, Inc. | 1997-05-14 | 61 | 0 |
| K902005 | MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE | Omega Medical Imaging, Inc. | 1990-09-20 | 139 | 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