Icad, Inc.
FDA 510(k) & PMA Approved Devices — 13 products
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Total Devices13
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K240417 | ProFound Detection (V4.0) | QDQ | 2024-11-08 | View |
| 510(k) | K211506 | PowerLook Density Assessment V4.0 | QIH | 2021-07-12 | View |
| 510(k) | K203822 | ProFound AI Software V3.0 | QDQ | 2021-03-12 | View |
| 510(k) | K191994 | ProFound AI Software V2.1 | QDQ | 2019-10-04 | View |
| 510(k) | K182373 | PowerLook Tomo Detection V2 Software | QDQ | 2018-12-06 | View |
| 510(k) | K180125 | PowerLook Density Assessment Software | LLZ | 2018-04-05 | View |
| 510(k) | K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 | JAD | 2016-02-25 | View |
| 510(k) | K123442 | XOFT AXXENT CERVICAL APPLICATORS | JAQ | 2013-02-27 | View |
| 510(k) | K122951 | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 | JAD | 2013-01-17 | View |
| 510(k) | K121517 | VERSAVUE ENTERPRISE SUITE | LLZ | 2012-07-20 | View |
| 510(k) | K091529 | ICAD VERALOOK CTC CAD SOFTWARE | JAK | 2010-08-04 | View |
| 510(k) | K090223 | ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 | LLZ | 2009-03-31 | View |
| 510(k) | K042697 | SECOND LOOK VIEWER | LLZ | 2004-11-19 | View |
No matching devices.
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