The following data is part of a premarket notification filed by Dde Mri Solutions Ltd with the FDA for Bit-motion.
| Device ID | K211039 |
| 510k Number | K211039 |
| Device Name: | BIT-Motion |
| Classification | System, Image Processing, Radiological |
| Applicant | DDE MRI Solutions LTD 2 Boeur Avraham Tel Aviv, IL 6912702 |
| Contact | Moti Sokolov |
| Correspondent | John J. Smith Hogan Lovells, US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-07 |
| Decision Date | 2021-12-15 |