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Sonio Detect (v3)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K252433

by Sonio

Identifiers

510(k) Number
K252433 FDA 510(k)
FDA Product Code
IYN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1550 FDA 510(k)
Regulation Number
892.1550 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Sonio Detect (v3) is an AI-powered ultrasound image analysis tool designed to assist radiologists and sonographers in evaluating ultrasound scans. It automatically detects anatomical structures, verifies image quality criteria, and ensures consistent examination standards in real-time, enhancing diagnostic confidence.

The device operates as a software component integrated into ultrasound systems, requiring no additional hardware or sterility considerations. Supplied as a digital solution, it is intended for use in clinical radiology settings and has received FDA 510(k) clearance under the product code IYN (Radiology). No physical storage or single-use/reusable classification applies, as it functions entirely within the Sonio Platform.

Frequently asked questions

How does Sonio Detect (v3) integrate into existing ultrasound systems and what hardware requirements does it have?

Sonio Detect (v3) is designed as a software component that integrates seamlessly into ultrasound systems through the Sonio Platform. Unlike traditional devices, it does not require additional hardware—it operates entirely within the existing system infrastructure. This means no extra equipment, cables, or physical storage is needed beyond the compatible ultrasound machine and platform setup.

Is Sonio Detect (v3) intended for use in specific clinical settings, and what types of users is it meant to assist?

Sonio Detect (v3) is specifically intended for clinical radiology settings, where radiologists and sonographers perform ultrasound evaluations. It assists these professionals by automating the detection of anatomical structures, verifying image quality, and ensuring consistent examination standards in real-time. This tool is not a standalone diagnostic device but rather a supportive AI-powered feature for trained imaging specialists.

How is Sonio Detect (v3) supplied, and does it require any special handling or storage conditions?

Since Sonio Detect (v3) is a digital solution, it is supplied exclusively as a software update or integration within the Sonio Platform. There are no physical components to store, sterilize, or dispose of—no single-use or reusable classification applies. Storage is managed digitally, and no special environmental conditions (e.g., temperature, humidity) are required beyond those needed for the underlying ultrasound system and platform.

What regulatory pathway was followed for FDA clearance of Sonio Detect (v3), and what does this mean for its use in the U.S.?

Sonio Detect (v3) received FDA clearance through a 510(k) submission, classified as *Substantially Equivalent* under product code IYN (Radiology). This means the device was determined to be as safe and effective as a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended use in radiology settings. The clearance was granted by the FDA’s Radiology (RA) Advisory Committee after review.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Sonio Announces FDA Clearance of the 3rd version of Sonio Detect, Sonio Detect and Sonio Pro: AI Ultrasound Tools | Sonio, Sonio Detect (v3) | Sonio radiology AI profile, Sonio Detect (v3) (K252433) — FDA 510 (k) | Innolitics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sonio

Sources (2)

  • FDA 510(k) K252433 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026