Ventripoint Medical System Plus (VMS+)

Basic Information

• Brand Name: Ventripoint Medical System Plus (VMS+)
• Primary DI: 07540263000025
• Version / Model: 3.0
• Company Name: VentriPoint Diagnostics Ltd
• Labeler DUNS: 243131807
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-05
• Public Version: 2
• Public Version Date: 2022-12-28
• Public Version Status: Update
• Public Device Record Key: 22ec6187-e6b9-47eb-a7ae-cba02d8ca557

Device Description

The VMS+ system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. The VMS+ system is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	892.1550	2
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40943	Radiology picture archiving and communication system workstation	A freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540263000025	GS1

Premarket Submissions

Submission Number	Supplement Number
K191493	000