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Ventripoint Medical System Plus (VMS+)

FDA UDI

Class II (US FDA UDI)

by VentriPoint Diagnostics Ltd

Identity

Trade Name
Ventripoint Medical System Plus (VMS+) FDA UDI
Generic Name
Radiology picture archiving and communication system workstation FDA UDI
Device Name
The VMS+ 4.0 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+ 4.0 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. FDA UDI
Model / Reference
4.0 FDA UDI
Description
The VMS+ 4.0 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+ 4.0 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. FDA UDI

Identifiers

Primary DI / UDI-DI
07540263000049 FDA UDI
510(k) Number
K241222 FDA UDI
FDA Product Code
QIH FDA UDI
LLZ FDA UDI
GMDN Term
Radiology picture archiving and communication system workstation FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Radiology picture archiving and communication system workstation

Ventripoint Medical System Plus (VMS+) by VentriPoint Diagnostics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology picture archiving and communication system workstation.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
VentriPoint Diagnostics Ltd

Sources (1)

  • FDA UDI 7f19080c-521c-4f4a-a50c-b84dad152136 34 fields · synced Jun 1, 2026