The following data is part of a premarket notification filed by Vital Images, Inc with the FDA for Vitrea View.
| Device ID | K163232 |
| 510k Number | K163232 |
| Device Name: | Vitrea View |
| Classification | System, Image Processing, Radiological |
| Applicant | Vital Images, Inc 5850 Opus Parkway Suite 300 Minnetonka, MN 55343 |
| Contact | Fei Li |
| Correspondent | Fei Li Vital Images, Inc 5850 Opus Parkway Suite 300 Minnetonka, MN 55343 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-17 |
| Decision Date | 2017-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853866003698 | K163232 | 000 |
| 00853866003735 | K163232 | 000 |
| 00853866003292 | K163232 | 000 |
| 00853866003308 | K163232 | 000 |
| 00853866003315 | K163232 | 000 |
| 00853866003346 | K163232 | 000 |
| 00853866003353 | K163232 | 000 |
| 00853866003377 | K163232 | 000 |
| 00853866003407 | K163232 | 000 |
| 00853866003650 | K163232 | 000 |
| 00853866003674 | K163232 | 000 |
| 00853866003728 | K163232 | 000 |