System, Image Processing, Radiological

Radiobotics ApS

The following data is part of a premarket notification filed by Radiobotics Aps with the FDA for Rbknee.

Pre-market Notification Details

Device IDK203696
510k NumberK203696
Device Name:RBknee
ClassificationSystem, Image Processing, Radiological
Applicant Radiobotics ApS Strandstrassde 21 4. Th Copenhagen,  DK Dk1255
ContactMartin Christian Axelsen
CorrespondentJohn J. Smith
Hogan Lovells US LLP 555 13th Street, NW Washington,  DC  20004
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-18
Decision Date2021-08-27

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