Data / Medical devices / France / Diagnoly

Diagnoly: FDA-registered device maker in Lyon 3e Arrondissement Rhone, France, 1 510(k) clearance

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

Diagnoly is registered with the FDA (registration 3033557977) in Lyon 3e Arrondissement Rhone, France. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 12, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3033557977
Address: Immeuble Terra Mundi 2 Place De Francfort, Lyon 3e Arrondissement Rhone, France, 69003
Owner or operator: DIAGNOLY (10091679)
Roles: Complaint file establishment, Manufacturer
First device listed: September 15, 2025
Registered through: 2026
Brand names listed: FETOLY

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	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
September 12, 2025	K251368	FETOLY	IYN	Substantially Equivalent	Diagnoly	accessdata.fda.gov

Compare with other makers

Updated September 12, 2025. 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.