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Ventripoint Medical System Plus (VMS+)
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref K191493Model VMS+ 3.0
Identity
- Trade Name
- Ventripoint Medical System Plus (VMS+) EUDAMEDFDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- Ventripoint Medical System Plus EUDAMEDThe 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. FDA UDI
- Model / Reference
- VMS+ 3.0 EUDAMEDK191493 EUDAMED3.0 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540263000025 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540263VMS+3YD EUDAMED
- Direct Marketing DI
- 07540263000025 EUDAMED
- 510(k) Number
- K191493 FDA UDI
- FDA Product Code
- LLZ FDA UDIIYN FDA UDIITX FDA UDIIYO FDA UDI
- EMDN Code
- Z11040192 ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI892.1550 FDA UDI892.1570 FDA UDI892.1560 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Unsafe FDA UDI
Ventripoint Medical System Plus (VMS+) by Ventripoint Diagnostics Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173810 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K191493 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7540263VMS+3YD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ventripoint Diagnostics Ltd.
- EUDAMED SRN
- CA-MF-000030095
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (3)
- EUDAMED ef730ef8-7f5c-4d43-bcc4-a7f3a0b3d5de 61 fields · synced Jul 21, 2026
- FDA UDI 22ec6187-e6b9-47eb-a7ae-cba02d8ca557 34 fields · synced May 30, 2026
- FDA 510(k) K173810 1 fields · synced May 18, 2026