Koios DS For Breast

Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer

Koios Medical, Inc.

The following data is part of a premarket notification filed by Koios Medical, Inc. with the FDA for Koios Ds For Breast.

Pre-market Notification Details

Device IDK190442
510k NumberK190442
Device Name:Koios DS For Breast
ClassificationComputer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Applicant Koios Medical, Inc. 500 7th Avenue, 8th Floor New York,  NY  10018
ContactLev Barinov
CorrespondentLev Barinov
Koios Medical, Inc. 500 7th Avenue, 8th Floor New York,  NY  10018
Product CodePOK  
CFR Regulation Number892.2060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-25
Decision Date2019-07-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08600025457074 K190442 000
00860002545707 K190442 000

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