7 devices · 4 companies · 2002 to 2024
iCAD, Inc.: AI-enabled devices on FDA's list
7 devices from iCAD, Inc., 2002 to 2024, from 4 companies across 3 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (6 of 7 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from iCAD, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| ProFound DetectionK240417 · 510(k) | Radiology | QDQ | database entry | |
| PowerLook Density Assessment V4.0K211506 · 510(k) | Radiology | QIH | database entry | |
| ProFound AI Software V3.0K203822 · 510(k) | Radiology | QDQ | database entry | |
| ProFound AI Software V2.1K191994 · 510(k) | Radiology | QDQ | database entry | |
| PowerLook Tomo Detection V2 SoftwareK182373 · 510(k) | Radiology | QDQ | database entry | |
| PowerLook Tomo Detection SoftwareP160009 · PMA | Radiology | MYN | database entry | |
| SECOND LOOKP010034 · PMA | Radiology | MYN | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.