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 |