Sonio: FDA-registered device maker in Paris, France, 5 510(k) clearances

Name: Sonio FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sonio is registered with the FDA (registration 3029937167) in Paris, France. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 4, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3029937167
Address: 147 rue d'Aboukir, Paris, France, 75002
Owner or operator: Sonio (10088709)
Roles: Complaint file establishment, Manufacturer
First device listed: October 4, 2023
Registered through: 2026
Brand names listed: Basic Image Processing, Image Manipulation, Sonio Detect, Sonio Detect v2, Sonio Detect v3, Sonio Suspect

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	POK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 4, 2026	K261519	Sonio Suspect	POK	Substantially Equivalent	Sonio	accessdata.fda.gov
March 16, 2026	K252433	Sonio Detect (v3)	IYN	Substantially Equivalent	Sonio	accessdata.fda.gov
February 21, 2025	K243614	Sonio Suspect	POK	Substantially Equivalent	Sonio	accessdata.fda.gov
April 26, 2024	K240406	Sonio Detect	IYN	Substantially Equivalent	Sonio	accessdata.fda.gov
July 25, 2023	K230365	Sonio Detect	IYN	Substantially Equivalent	Sonio	accessdata.fda.gov

Compare with other makers

Updated June 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.