Cleared Traditional

K230365 - Sonio Detect

K230365 is the FDA 510(k) clearance for Sonio Detect by Sonio. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K230365 · Sonio · Radiology device
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Jul 2023
Decision
165d
Days
Class 2
Risk

K230365 is an FDA 510(k) clearance for the Sonio Detect. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Sonio (Paris, FR). The FDA issued a Cleared decision on July 25, 2023 after a review of 165 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 K230365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2023
Decision Date July 25, 2023
Days to Decision 165 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 107d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 779
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K230365.
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K230346 · Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC · Jun 2023
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K223917 · Vinno Technology (Suzhou) Co.,Ltd · Jun 2023