Sonio Suspect— 510(k) K261519

Substantially Equivalent

Sonio

FDA 510(k) clearance K261519 for Sonio Suspect, Substantially Equivalent on 2026-06-04. Applicant: Sonio. Device class: 2.

Clearance details

Applicant: Sonio
Product code: Code POK
Device class: Class 2
Regulation: 21 CFR 892.2060
Advisory panel: Radiology
Date received: 2026-05-07
Decision date: 2026-06-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.