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510(k) K261519

Sonio Suspect by Sonio — Product Code POK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2026
Date Received
May 7, 2026
Clearance Type
Special
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 Sonio

  • K252433 — Sonio Detect (v3) (March 16, 2026)
  • K243614 — Sonio Suspect (February 21, 2025)
  • K240406 — Sonio Detect (April 26, 2024)
  • K230365 — Sonio Detect (July 25, 2023)

Other clearances for product code POK

  • K254161 — Automated Aortic Stenosis Software (AutoAS) (March 27, 2026)
  • K251769 — RevealAI-Lung (January 30, 2026)
  • 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)