iCAD, Inc.
FDA Regulatory Profile
iCAD, Inc. appears in FDA public data with 1 recall, 14 510(k) clearances, 8 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1243-2015, Class II) was initiated on January 21, 2015. Its most recent 510(k) clearance was granted on November 8, 2024.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 14
- Inspections
- 8
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1243-2015 | Class II | DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 | January 21, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240417 | ProFound Detection (V4.0) | November 8, 2024 |
| K211506 | PowerLook Density Assessment V4.0 | July 12, 2021 |
| K203822 | ProFound AI Software V3.0 | March 12, 2021 |
| K191994 | ProFound AI Software V2.1 | October 4, 2019 |
| K182373 | PowerLook Tomo Detection V2 Software | December 6, 2018 |
| K180125 | PowerLook Density Assessment Software | April 5, 2018 |
| K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 | February 25, 2016 |
| K141343 | AXXENT CERVICAL APPLICATOR | September 5, 2014 |
| K123442 | XOFT AXXENT CERVICAL APPLICATORS | February 27, 2013 |
| K122951 | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 | January 17, 2013 |
| K121517 | VERSAVUE ENTERPRISE SUITE | July 20, 2012 |
| K091529 | ICAD VERALOOK CTC CAD SOFTWARE | August 4, 2010 |
| K090223 | ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 | March 31, 2009 |
| K042697 | SECOND LOOK VIEWER | November 19, 2004 |