Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011688715

FEI Number

3011688715

Entity Name

SONOSCANNER SARL

City/State/Country

Ivry-sur-Seine Val-de-Marne, FR

Establishment Address

6 rue Andre Voguet, Ivry-sur-Seine Val-de-Marne 94200, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sonoscanner (Owner Number: 10049253)

Owner / Operator Contact Address

16192 Coastal Hwy, Lewes, DE 19958, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232285

PMA Number

N/A

All Registered Proprietary Names

U-Lite EXP InVisus EXP U-Lite InVisus SLP T Lite PRO Elite U Lite PRO InVisus Pro T Lite PRO U Lite PRO Elite

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-10-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-10-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-10-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-05-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-05-02
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-05-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-01-15
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-01-15
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-01-15

Official Correspondent

Etienne Richard

US Agent Details

kristi LEIGH Business: SMITH ASSOCIATES Email: klmarks@fdaconsultants.com Phone: (888) 7299674

Related Public Records

Same Entity

Sonoscanner

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K191007	Supersonic Imagine	Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems	2019-10-25
K974588	Rimed , Ltd.	INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD	1998-08-07
K142628	Siemens Medi Cal Solutions, Inc.	Acuson SC2000 Diagnostic Ultrasound System	2014-10-10
K132171	Supersonic Imagine	AIXPLORER	2013-09-24
K222441	Bk Medical Aps	Ultrasound System 2300	2022-12-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0189-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022	FujiFilm Healthcare Americas Corporation	2	Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024	FUJIFILM Healthcare Americas Corporation	2	Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

Similar Registrations

Registration Number	Establishment Name	Location
3029744051	LYSIS HEALTHCARE GMBH	Graz Steiermark, AT
3014574557	ADECHOTECH	NAVEIL Loir-et-Cher, FR
3012081348	THE SENTINEL IMAGING GROUP, INC	Clarks Summit, PA, US
3025786376	ACO HEALTHCARE CO., LTD.	Taoyuan City, TW
3004752776	Compumedics Germany GmbH	Singen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011688715. Last updated year: 2026. Please use registration number 3011688715 when referencing this establishment in official correspondence.