OptiVu ROSA MxR

System, Image Processing, Radiological

Orthosoft, Inc. (d/b/a Zimmer CAS)

The following data is part of a premarket notification filed by Orthosoft, Inc. (d/b/a Zimmer Cas) with the FDA for Optivu Rosa Mxr.

Pre-market Notification Details

Device IDK220733
510k NumberK220733
Device Name:OptiVu ROSA MxR
ClassificationSystem, Image Processing, Radiological
Applicant Orthosoft, Inc. (d/b/a Zimmer CAS) 75 Queen St., Suite 3300 Montreal,  CA H3C 2N6
ContactPaul Hardy
CorrespondentPaul Hardy
Orthosoft, Inc. (d/b/a Zimmer CAS) 75 Queen St., Suite 3300 Montreal,  CA H3C 2N6
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-14
Decision Date2022-07-29

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