The following data is part of a premarket notification filed by Vital Images, Inc. with the FDA for Vitrea2, Version 3.4 Medical Image Processing Software.
| Device ID | K032748 |
| 510k Number | K032748 |
| Device Name: | VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | VITAL IMAGES, INC. 3300 FERNBROOK LN. NORTH SUITE 200 Plymouth, MN 55447 |
| Contact | Stephen S Anderson |
| Correspondent | Stephen S Anderson VITAL IMAGES, INC. 3300 FERNBROOK LN. NORTH SUITE 200 Plymouth, MN 55447 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-05 |
| Decision Date | 2003-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853866003414 | K032748 | 000 |
| 00850025268295 | K032748 | 000 |
| 00850025268240 | K032748 | 000 |
| 00850025268233 | K032748 | 000 |
| 00850025268226 | K032748 | 000 |
| 00850025268219 | K032748 | 000 |
| 00853866003766 | K032748 | 000 |
| 00853866003742 | K032748 | 000 |
| 00853866003667 | K032748 | 000 |
| 00853866003681 | K032748 | 000 |
| 00853866003179 | K032748 | 000 |
| 00853866003186 | K032748 | 000 |
| 00853866003193 | K032748 | 000 |
| 00853866003216 | K032748 | 000 |
| 00853866003322 | K032748 | 000 |
| 00853866003339 | K032748 | 000 |
| 00853866003360 | K032748 | 000 |
| 00853866003384 | K032748 | 000 |
| 00850025268301 | K032748 | 000 |