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510(k) K190442

Koios DS for Breast by Koios Medical, Inc. — Product Code POK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2019
Date Received
February 25, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class
Class II
Regulation Number
892.2060
Review Panel
RA
Submission Type

Assist users in characterizing lesions identified on acquired medical images

Other clearances by Koios Medical, Inc.

  • K242130 — Koios DS (November 15, 2024)
  • K212616 — Koios DS (December 16, 2021)

Other clearances for product code POK

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  • K252294 — Fetal EchoScan (v1.2) (December 8, 2025)
  • K250221 — StrokeSENS ASPECTS Software Application (July 1, 2025)
  • K251071 — Fetal EchoScan (v1.1) (May 2, 2025)
  • K243614 — Sonio Suspect (February 21, 2025)
  • K243294 — Brainomix 360 e-ASPECTS (February 14, 2025)
  • K242130 — Koios DS (November 15, 2024)
  • K242342 — Fetal EchoScan (November 14, 2024)
  • K241245 — EchoSolv AS (October 4, 2024)
  • K234141 — AISAP Cardio V1.0 (August 1, 2024)