Tissue Differentiation Intelligence LLC

Address:234 NE 4th Avenue,Delray Beach,FL,33483,US

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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 Doppler, Ultrasonic (IYN) (1) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (1) Transducer, Ultrasonic, Diagnostic (ITX) (1)

Premarket Exempt

Clear

Beluga1 - 00860001239348 Catalog Number :

Device Description : Beluga1 Imaging Probe

Device Class : 2

Duns Number: 081327336

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

SonoVision - 00860001239355 Catalog Number :

Device Description : SonoVision Ultrasound Imaging Console

Device Class : 2

Duns Number: 081327336

Premarket Exempt : No

Product Code : IYN, IYO

Prescription Use : Yes

Device Count : 1

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