Sonio

Name: AI Device Index: FDA-listed AI-enabled medical devices
Creator: AI Device Index
License: https://creativecommons.org/licenses/by/4.0/

5 AI-enabled medical devices from Sonio on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

Decision	Number	Device	Company	Panel
2026-06-04	K261519	Sonio Suspect	Sonio	Radiology
2026-03-16	K252433	Sonio Detect (v3)	Sonio	Radiology
2025-02-21	K243614	Sonio Suspect	Sonio	Radiology
2024-04-26	K240406	Sonio Detect	Sonio	Radiology
2023-07-25	K230365	Sonio Detect	Sonio	Radiology

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