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510(k) K243614

Sonio Suspect by Sonio — Product Code POK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2025
Date Received
November 22, 2024
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 Sonio

  • K240406 — Sonio Detect (April 26, 2024)
  • K230365 — Sonio Detect (July 25, 2023)

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