Cleared Traditional

K243614 - Sonio Suspect (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243614 · Sonio · Radiology device
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Feb 2025
Decision
91d
Days
Class 2
Risk

K243614 is an FDA 510(k) clearance for the Sonio Suspect. Classified as Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (product code POK), Class II - Special Controls.

Submitted by Sonio (Paris, FR). The FDA issued a Cleared decision on February 21, 2025 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2060 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sonio devices

Submission Details

510(k) Number K243614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 107d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code POK Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2060
Definition Assist Users In Characterizing Lesions Identified On Acquired Medical Images
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - POK Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer

All 20
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