Icad, Inc.
Medical device manufacturer in Nashua, NH.
14510(k) clearances
4PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K240417 | ProFound Detection (V4.0)QDQ · Traditional | 11/08/2024SE |
| K211506 | PowerLook Density Assessment V4.0QIH · Traditional | 07/12/2021SE |
| K203822 | ProFound AI Software V3.0QDQ · Special | 03/12/2021SE |
| K191994 | ProFound AI Software V2.1QDQ · Traditional | 10/04/2019SE |
| K182373 | PowerLook Tomo Detection V2 SoftwareQDQ · Traditional | 12/06/2018SE |
| K180125 | PowerLook Density Assessment SoftwareLLZ · Traditional | 04/05/2018SE |
| K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200JAD · Traditional | 02/25/2016SE |
| K141343 | Axxent Cervical ApplicatorJAD · Traditional | 09/05/2014SE |
| K123442 | Xoft Axxent Cervical ApplicatorsJAQ · Traditional | 02/27/2013SE |
| K122951 | Xoft Axxent Electronic Brachytherapy System Model 110JAD · Traditional | 01/17/2013SE |
| K121517 | Versavue Enterprise SuiteLLZ · Special | 07/20/2012SE |
| K091529 | Icad Veralook CTC Cad SoftwareJAK · Traditional | 08/04/2010SE |
| K090223 | Icad Breast Interventional Planning Software, Model D70024LLZ · Traditional | 03/31/2009SE |
| K042697 | Second Look ViewerLLZ · Traditional | 11/19/2004SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1243-2015 Class II | DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2A device malfunction may cause the biopsy needle to fail to reach the intended target. If location… | 01/21/2015Terminated |
| Z-0654-2009 | CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.Software modules not approved for this indication. | 12/09/2008Terminated |
| Z-0653-2009 | CAD SCIENCES LLC 3TP TheraMapTM Software, for oncology treatment planning, assessment…Software modules not approved for this indication. | 12/09/2008Terminated |