FDA 510(k), K212616, Koios DS

510(K) Number: K212616
Device Name: Koios DS
Manufacturer: Koios Medical, Inc.
Device Classification Name: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Regulation Number: 892.2060
Classification Product Code: POK
Date Received: 08/18/2021
Decision Date: 12/16/2021
Regulation Medical Specialty: Radiology

413 pages (2,005 of 2,418 original pages are fully redacted)