Data / Medical devices / France / Sonoscanner Sarl

Sonoscanner Sarl: FDA-registered device maker in Ivry-sur-Seine Val-de-Marne, France, 4 510(k) clearances

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

Sonoscanner Sarl is registered with the FDA (registration 3011688715) in Ivry-sur-Seine Val-de-Marne, France. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 11, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Sonoscanner Sarl

FDA registration number: 3011688715
Address: 6 rue Andre Voguet, Ivry-sur-Seine Val-de-Marne, France, 94200
Owner or operator: Sonoscanner (10049253)
Roles: Manufacturer
First device listed: May 2, 2015
Registered through: 2026
Brand names listed: InVisus EXP, InVisus Pro, InVisus SLP, T Lite PRO, T Lite PRO Elite, T-Lite, U Lite PRO, U Lite PRO Elite and more

Devices it lists

Device	Product code	Class	Role	Source
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	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
January 11, 2024	K232285	U-Lite PRO	IYN	Substantially Equivalent	Sonoscanner Sarl	accessdata.fda.gov
October 30, 2020	K201988	T-Lite	IYN	Substantially Equivalent	Sonoscanner	accessdata.fda.gov
August 3, 2017	K171164	U-Lite EXP	IYN	Substantially Equivalent	Sonoscanner	accessdata.fda.gov
March 18, 2015	K143601	U-Lite	IYN	Substantially Equivalent	Sonoscanner Sarl	accessdata.fda.gov

Compare with other makers

Updated January 11, 2024. 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.