The following data is part of a premarket notification filed by Icad, Inc. with the FDA for Versavue Enterprise Suite.
| Device ID | K121517 |
| 510k Number | K121517 |
| Device Name: | VERSAVUE ENTERPRISE SUITE |
| Classification | System, Image Processing, Radiological |
| Applicant | ICAD, INC. 98 SPIT BROOK ROAD SUITE 100 Nashua, NH 03062 |
| Contact | Michael A Patz |
| Correspondent | Michael A Patz ICAD, INC. 98 SPIT BROOK ROAD SUITE 100 Nashua, NH 03062 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-22 |
| Decision Date | 2012-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838086630 | K121517 | 000 |