The following data is part of a premarket notification filed by Icad Inc. with the FDA for Profound Ai Software V3.0.
| Device ID | K203822 |
| 510k Number | K203822 |
| Device Name: | ProFound AI Software V3.0 |
| Classification | Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer |
| Applicant | iCAD Inc. 98 Spit Brook Rd. Suite 100 Nashua, NH 03062 |
| Contact | Heather Reed |
| Correspondent | Heather Reed iCAD Inc. 98 Spit Brook Rd. Suite 100 Nashua, NH 03062 |
| Product Code | QDQ |
| CFR Regulation Number | 892.2090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-29 |
| Decision Date | 2021-03-12 |