The following data is part of a premarket notification filed by Icad Inc. with the FDA for Powerlook Tomo Detection V2 Software.
| Device ID | K182373 |
| 510k Number | K182373 |
| Device Name: | PowerLook Tomo Detection V2 Software |
| Classification | Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer |
| Applicant | iCAD Inc. 98 Spitbrook Rd. Suite 100 Nashua, NH 03062 |
| Contact | John Delucia |
| Correspondent | John Delucia iCAD Inc. 98 Spit Brook Rd. Suite 100 Nashua, NH 03062 |
| Product Code | QDQ |
| CFR Regulation Number | 892.2090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-31 |
| Decision Date | 2018-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858012005939 | K182373 | 000 |
| 00858012005960 | K182373 | 000 |