Cleared Traditional

Sonio Suspect

K243614 · Sonio · Radiology

Feb 2025

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K243614 is an FDA 510(k) clearance for the Sonio Suspect, a Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (Class II — Special Controls, product code POK), submitted by Sonio (Paris, FR). The FDA issued a Cleared decision on February 21, 2025, 91 days after receiving the submission on November 22, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2060.

Submission Details

510(k) Number	K243614 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2024
Decision Date	February 21, 2025
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	POK — Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2060
Definition	Assist Users In Characterizing Lesions Identified On Acquired Medical Images