VIASONIX LTD

Address:10 Hamelacha St.,RAANANA Central,IL

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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

Transducer, Ultrasonic, Diagnostic (ITX) (6) Transducer, Ultrasonic (JOP) (4) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (2)

Premarket Exempt

Clear

Falcon - 07290016880007 Catalog Number : PVC0077

Device Description : intended for use in the noninvasive evaluation of peripheral vascular pathology intended for use in the noninvasive evaluation of peripheral vascular pathology in patients

Device Class : 2

Duns Number: 533070236

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

Falcon - 07290016880014 Catalog Number : PVC0078

Device Description : intended for use in the noninvasive evaluation of peripheral vascular pathology intended for use in the noninvasive evaluation of peripheral vascular pathology in patients

Device Class : 2

Duns Number: 533070236

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

Falcon - 07290016880021 Catalog Number : PVC0079

Device Description : intended for use in the noninvasive evaluation of peripheral vascular pathology intended for use in the noninvasive evaluation of peripheral vascular pathology in patients

Device Class : 2

Duns Number: 533070236

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

Dolphin - 07290016880038 Catalog Number :

Device Description : The Dolphin/4D is a medical Doppler device intended for noninvasive measurements The Dolphin/4D is a medical Doppler device intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. TheDolphin/4D system can be used in hospitals, clinics and physician offices

Device Class : 2

Duns Number: 533070236

Premarket Exempt : No

Product Code : IYN, ITX

Prescription Use : Yes

Device Count : 1

Dolphin - 07290016880045 Catalog Number :

Device Description : The Dolphin/IQ is a medical Doppler device intended for noninvasive measurements The Dolphin/IQ is a medical Doppler device intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. TheDolphin/IQ system can be used in hospitals, clinics and physician offices

Device Class : 2

Duns Number: 533070236

Premarket Exempt : No

Product Code : ITX, IYN

Prescription Use : Yes

Device Count : 1

4 MHz probe - 07290016880052 Catalog Number :

Device Description : 4 MHz probe is an ultrasonic transducer which generate acoustic signals and also 4 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with the Dolphin system for noninvasive measurements of blood flow velocities in arteries and veins

Device Class : 2

Duns Number: 533070236

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

8 MHz probe - 07290016880069 Catalog Number :

Device Description : 8 MHz probe is an ultrasonic transducer which generate acoustic signals and also 8 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with the Dolphin system for noninvasive measurements of blood flow velocities in arteries and veins

Device Class : 2

Duns Number: 533070236

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

10 MHz probe - 07290016880076 Catalog Number :

Device Description : 10 MHz probe is an ultrasonic transducer which generate acoustic signals and als 10 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with the FALCON system for noninvasive measurements of blood flow velocities in arteries and veins

Device Class : 2

Duns Number: 533070236

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

1.6 MHz probe - 07290016880083 Catalog Number :

Device Description : 1.6 MHz probe is an ultrasonic transducer which generate acoustic signals and al 1.6 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with the Dolphin system for noninvasive measurements of blood flow velocities in arteries and veins

Device Class : 2

Duns Number: 533070236

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

2 MHz probe - 07290016880090 Catalog Number :

Device Description : 2 MHz probe is an ultrasonic transducer which generate acoustic signals and also 2 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with the Dolphin system for noninvasive measurements of blood flow velocities in arteries and veins

Device Class : 2

Duns Number: 533070236

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

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