VentriPoint Diagnostics Ltd

Address:2 Sheppard Avenue East,Toronto Ontario,CA

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (2) System, Image Processing, Radiological (LLZ) (1) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (1) Transducer, Ultrasonic, Diagnostic (ITX) (1)

Premarket Exempt

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Ventripoint Medical System Plus (VMS+) - 07540263000018 Catalog Number :

Device Description : The VMS+ system is an adjunct to existing ultrasound imaging systems and is inte 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 Class : 2

Duns Number: 243131807

Premarket Exempt : No

Product Code : IYN

Prescription Use : Yes

Device Count : 1

Ventripoint Medical System Plus (VMS+) - 07540263000025 Catalog Number :

Device Description : The VMS+ system is an adjunct to existing ultrasound imaging systems and is inte 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 Class : 2

Duns Number: 243131807

Premarket Exempt : No

Product Code : LLZ, IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

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