StoneChecker

System, Image Processing, Radiological

Imaging Biometrics, LLC

The following data is part of a premarket notification filed by Imaging Biometrics, Llc with the FDA for Stonechecker.

Pre-market Notification Details

Device IDK191530
510k NumberK191530
Device Name:StoneChecker
ClassificationSystem, Image Processing, Radiological
Applicant Imaging Biometrics, LLC 13416 Watertown Plank Road, Suite 260 Elm Grove,  WI  53122
ContactTimothy Dondlinger
CorrespondentTimothy Dondlinger
Imaging Biometrics, LLC 13416 Watertown Plank Road, Suite 260 Elm Grove,  WI  53122
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-10
Decision Date2019-09-26
Summary:summary

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