MEDGE PLATFORMS INC

MEDGE PLATFORMS INC

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Filters

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 Echo, Ultrasonic (IYO) (2)

Premarket Exempt

No

Clear

Sonocubic 3D Ultrasound Software - B118314160 Catalog Number :

Device Description : Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, an Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.

Device Class : 2

Duns Number: 122782324

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 1

Sonocubic 3D Ultrasound Software - B118314170 Catalog Number :

Device Description : Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, an Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.

Device Class : 2

Duns Number: 122782324

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 1

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