MirrorMe3D Modeling System

System, Image Processing, Radiological

MirrorMe3D, LLC

The following data is part of a premarket notification filed by Mirrorme3d, Llc with the FDA for Mirrorme3d Modeling System.

Pre-market Notification Details

Device IDK212981
510k NumberK212981
Device Name:MirrorMe3D Modeling System
ClassificationSystem, Image Processing, Radiological
Applicant MirrorMe3D, LLC 222 W 37th St., Suite 1501 New York,  NY  10018
ContactJordan Mills
CorrespondentJordan Mills
MirrorMe3D, LLC 222 W 37th St., Suite 1501 New York,  NY  10018
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-17
Decision Date2022-04-22

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