The following data is part of a premarket notification filed by Icad, Inc with the FDA for Powerlook Density Assessment Software.
| Device ID | K180125 |
| 510k Number | K180125 |
| Device Name: | PowerLook Density Assessment Software |
| Classification | System, Image Processing, Radiological |
| Applicant | iCAD, Inc 98 Spitbrook Road Suite 100 Nashua, NH 03062 |
| Contact | John Delucia |
| Correspondent | John Delucia iCAD, Inc 98 Spitbrook Road Suite 100 Nashua, NH 03062 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-16 |
| Decision Date | 2018-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858012005922 | K180125 | 000 |
| 00850008977190 | K180125 | 000 |
| 00850008977183 | K180125 | 000 |