Ventripoint Medical System Plus (VMS+)

GUDID 07540263000049

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.

VentriPoint Diagnostics Ltd

Radiology picture archiving and communication system workstation

• Primary Device ID: 07540263000049
• NIH Device Record Key: 7f19080c-521c-4f4a-a50c-b84dad152136
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ventripoint Medical System Plus (VMS+)
• Version Model Number: 4.0
• Company DUNS: 243131807
• Company Name: VentriPoint Diagnostics Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540263000049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241222

FDA Product Code

• QIH: Automated Radiological Image Processing Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-28
• Device Publish Date: 2025-03-20

On-Brand Devices [Ventripoint Medical System Plus (VMS+)]

• 07540263000018: The VMS+ system is an adjunct to existing ultrasound imaging systems and is intended to record,
• 07540263000049: The VMS+ 4.0 system is an adjunct to existing ultrasound imaging systems and is intended to reco