The following data is part of a premarket notification filed by Icad, Inc. with the FDA for Icad Veralook Ctc Cad Software.
| Device ID | K091529 |
| 510k Number | K091529 |
| Device Name: | ICAD VERALOOK CTC CAD SOFTWARE |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | ICAD, INC. 98 SPIT BROOK ROAD SUITE 100 Nashua, NH 03062 |
| Contact | John A Delucia |
| Correspondent | John A Delucia ICAD, INC. 98 SPIT BROOK ROAD SUITE 100 Nashua, NH 03062 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-22 |
| Decision Date | 2010-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858012005908 | K091529 | 000 |
| 00858012005915 | K091529 | 000 |
| 00858012005892 | K091529 | 000 |
| 00858012005885 | K091529 | 000 |