The following data is part of a premarket notification filed by Icad Inc. with the FDA for Second Look Viewer.
| Device ID | K042697 |
| 510k Number | K042697 |
| Device Name: | SECOND LOOK VIEWER |
| Classification | System, Image Processing, Radiological |
| Applicant | ICAD INC. 2689 COMMONS BLVD., SUITE 100 Beavercreek, OH 45431 |
| Contact | John Rosenstengel |
| Correspondent | John Rosenstengel ICAD INC. 2689 COMMONS BLVD., SUITE 100 Beavercreek, OH 45431 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-30 |
| Decision Date | 2004-11-19 |
| Summary: | summary |