MyPAO Planning Report

System, Image Processing, Radiological

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mypao Planning Report.

Pre-market Notification Details

Device IDK200589
510k NumberK200589
Device Name:MyPAO Planning Report
ClassificationSystem, Image Processing, Radiological
Applicant Medacta International SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-06
Decision Date2021-02-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630971243378 K200589 000
07630971243378 K200589 000

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