Automated Radiological Image Processing Software

ClariPi Inc.

The following data is part of a premarket notification filed by Claripi Inc. with the FDA for Clarisigmam.

Pre-market Notification Details

Device IDK203785
510k NumberK203785
Device Name:ClariSIGMAM
ClassificationAutomated Radiological Image Processing Software
Applicant ClariPi Inc. 3F, 70-15, Ihwajang-gil Seoul,  KR 03088
ContactHyun-sook Park
CorrespondentHarry Park
ClariPi Detroit Office 1645 Park Creek Ct. Rochester Hills Detroit,  MI  48309
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-28
Decision Date2021-09-10

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