Home › Icad, Inc. › PowerLook AMP SLD Philips OUS
PowerLook AMP SLD Philips OUS
Icad, Inc. · Model DSC010-07-EU · UDI-DI 00858012005151
0
510(k) clearances
5
Adverse events
3
Recalls
28
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-04-06 | GA Industries | GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not submitted for approval to the FDA prior to product release. |
| 2006-05-04 | Riverain Medical Group | The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0 |
| 2006-05-04 | Riverain Medical Group | The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.