Koios DS

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.

Pre-market Notification Details

Device IDK212616
510k NumberK212616
Device Name:Koios DS
ClassificationComputer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Applicant Koios Medical, Inc. 242 West 38th Street, 14th Floor New York,  NY  10018
ContactPatricia Setti-laperch
CorrespondentPatricia Setti-laperch
Koios Medical, Inc. 242 West 38th Street, 14th Floor New York,  NY  10018
Product CodePOK  
CFR Regulation Number892.2060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-18
Decision Date2021-12-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860002545714 K212616 000

Trademark Results [Koios DS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KOIOS DS
KOIOS DS
88421199 not registered Live/Pending
KOIOS MEDICAL, INC
2019-05-08

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.