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 |