VENTRIPOINT DIAGNOSTICS LTD.

FDA Device Registration & Listing · Toronto Ontario, CA · Registration 3007194257

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007194257
FEI Number
3007194257
Entity Name
VENTRIPOINT DIAGNOSTICS LTD.
City/State/Country
Toronto Ontario, CA
Establishment Address
18 Hook Avenue, Unit 101, Toronto Ontario M6P1T4, CA
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Ventripoint Diagnostics Ltd. (Owner Number: 10046630)
Owner / Operator Contact Address
18 Hook Avenue, Unit 101, Toronto, CA-ON M6P1T4, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K191493
PMA Number
N/A

All Registered Proprietary Names

Ventripoint Medical System Plus (Vms+) 3

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 2020-01-09
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-01-09
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-01-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-01-09

Official Correspondent

Aaron Zhang

US Agent Details

Floyd Larson Business: PAXMED INTERNATIONAL, LLC Email: flarson@paxmed.com Phone: (858) 7921235

Related Public Records

Same Entity

Ventripoint Diagnostics Ltd.
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 3007194257. Last updated year: 2026. Please use registration number 3007194257 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.