The following data is part of a premarket notification filed by Advantis Medical Imaging Single Member P.c. with the FDA for Brainance Md.
| Device ID | K202808 |
| 510k Number | K202808 |
| Device Name: | Brainance MD |
| Classification | System, Image Processing, Radiological |
| Applicant | Advantis Medical Imaging Single Member P.C. Eleftheriou Venizelou Avenue 99 Nea Smirni Athens, GR 17123 |
| Contact | Paris Ziogkas |
| Correspondent | Paris Ziogkas Advantis Medical Imaging Single Member P.C. Eleftheriou Venizelou Avenue 99 Nea Smirni Athens, GR 17123 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-23 |
| Decision Date | 2021-10-14 |