OMNERA 500A
Arcoma AB · Model Precision i5 · UDI-DI 07350008750098
1
510(k) clearances
3
Adverse events (1 deaths)
1
Recalls
25
Facilities
Description
Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-24 | Phadia Ab | Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA w |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.