The following data is part of a premarket notification filed by Evolve Pacs Inc. with the FDA for Evolve Pacs.
| Device ID | K211863 |
| 510k Number | K211863 |
| Device Name: | EVolve PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | eVolve PACS Inc. 3924 Bryn Mawr Drive Dallas, TX 75225 |
| Contact | David Donahue |
| Correspondent | Carl Alletto OTech Inc. 8317 Belew Drive Mckinney, TX 75071 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-16 |
| Decision Date | 2021-08-12 |