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Sonio Detect (v3)

by Sonio

510(k) K252433

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252433↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK252433 Date16 Mar 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K252433 decided 16 Mar 2026 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
IYN
Device class
Class II
Regulation
21 CFR Part 892.1550
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

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