The following data is part of a premarket notification filed by Vital Images, Inc. with the FDA for Lung Analysis Software.
| Device ID | K151283 |
| 510k Number | K151283 |
| Device Name: | Lung Analysis Software |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Vital Images, Inc. 5850 Opus Parkway Suite 300 Minnetonka, MN 55343 |
| Contact | Parthiv Shah |
| Correspondent | Parthiv Shah Vital Images, Inc. 5850 Opus Parkway Suite 300 Minnetonka, MN 55343 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-14 |
| Decision Date | 2015-10-30 |
| Summary: | summary |