FDA.report

510(k) K242130

Device
Koios DS
Applicant
Koios Medical, Inc.
510(k) number
K242130
Product code
POK
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-15
Date received
2024-07-22
Regulation
892.2060
Classification name
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Michael Bocchinfuso
Address
242 W. 38th St. 14th Floor New York NY US 10018 10018

FDA Registration Numbers

Source Documents

510(k) summary PDF

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