Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012747207

FEI Number

3012747207

Entity Name

CLARIUS MOBILE HEALTH CORP.

City/State/Country

Vancouver British Columbia, CA

Establishment Address

205-2980 Virtual Way, Vancouver British Columbia V5M 4X3, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Clarius Mobile Health Corp. (Owner Number: 10053451)

Owner / Operator Contact Address

205-2980 Virtual Way, Vancouver, CA-BC V5M 4X3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250226

PMA Number

N/A

All Registered Proprietary Names

Clarius Scanner PAL HD3 Clarius Ultrasound Scanner PAL HD3 Clarius Prostate AI Li-ion Battery Charger Clarius Ultrasound System Clarius Ultrasound Scanner Clarius Scanner C3 Clarius Scanner L7 Clarius C3 Ultrasound Scanner Clarius L7 Ultrasound Scanner Rechargeable Li-ion Battery Pack Clarius Ultrasound Scanner C3 HD3; C7 HD3; EC7 HD3; L7 HD3; L15 HD3; PA HD3; L20 HD3; Clarius Fan HD3; Clarius Power Fan HD3; Clarius Charger HD3 Clarius Ultrasound Scanner Viera Battery Charger Synergy Ultrasound Battery Basic MSK Ultrasound Curvilinear Scanner Synergy MSK Ultrasound Scanner Clarius Scanner L7 Basic MSK Ultrasound Linear Scanner Synergy MSK Ultrasound Linear Scanner Synergy MSK Ultrasound Curvilinear Scanner Clarius Clip-on C3-L Clarius Scanner C7 Viera Portable Breast Ultrasound Linear Scanner Clarius Scanner C3 Viera Rechargeable Li-ion Battery Synergy Ultrasound Single Charger Clarius Charger Clarius Battery Clarius MSK AI Clarius AI Clarius Bladder AI Clarius OB AI Clarius Ejection Fraction AI Clarius Median Nerve AI

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	2024-01-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-01-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-01-12
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-03-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-12-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-12-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-12-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-12-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-12-15
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-12-15
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-09-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-09-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-09-27
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-01-12
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-01-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-12-18
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-12-18
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-05-06
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-03-20

Official Correspondent

Laurent Pelissier

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Clarius Mobile Health Corp.

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 3012747207. Last updated year: 2026. Please use registration number 3012747207 when referencing this establishment in official correspondence.