BIT-Motion

System, Image Processing, Radiological

DDE MRI Solutions LTD

The following data is part of a premarket notification filed by Dde Mri Solutions Ltd with the FDA for Bit-motion.

Pre-market Notification Details

Device IDK211039
510k NumberK211039
Device Name:BIT-Motion
ClassificationSystem, Image Processing, Radiological
Applicant DDE MRI Solutions LTD 2 Boeur Avraham Tel Aviv,  IL 6912702
ContactMoti Sokolov
CorrespondentJohn J. Smith
Hogan Lovells, US LLP Columbia Square 555 Thirteenth Street, NW Washington,  DC  20004
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-07
Decision Date2021-12-15

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