Data / Medical devices / France / E-Scopics

E-Scopics: FDA-registered device maker in Aix-en-Provence Bouches-du-Rhone, France, 4 510(k) clearances

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

E-Scopics is registered with the FDA (registration 3026405201) in Aix-en-Provence Bouches-du-Rhone, France. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 9, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3026405201
Address: 235 rue Leon Foucault Parc de la Duranne, Aix-en-Provence Bouches-du-Rhone, France, 13100
Owner or operator: E-Scopics (10087219)
Roles: Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
First device listed: March 17, 2023
Registered through: 2026
Brand names listed: Hepatoscope, Hepatoscope App, e.C5-1 probe, eC5-1 probe

Devices it lists

Device	Product code	Class	Role	Source
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Complaint file establishment, Exporter to the US, Manufacturer, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Exporter to the US, Manufacturer, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment, Exporter to the US, Manufacturer, Specification developer	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 9, 2026	K260748	ES-Series	IYN	Substantially Equivalent	E-Scopics	accessdata.fda.gov
April 29, 2026	K260589	ES-Series	IYN	Substantially Equivalent	E-Scopics	accessdata.fda.gov
September 26, 2023	K232336	ES Series V2	IYN	Substantially Equivalent	E-Scopics	accessdata.fda.gov
January 11, 2022	K213102	ES1 System	IYN	Substantially Equivalent	E-Scopics	accessdata.fda.gov

Compare with other makers

Updated June 9, 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.