ECHONOUS, INC.

Address:8310 154th Ave NE,Redmond,WA,98052,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 Echo, Ultrasonic (IYO) (7) Transducer, Ultrasonic, Diagnostic (ITX) (3) Electrocardiograph (DPS) (1) Stethoscope, Electronic (DQD) (1) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (1)

Premarket Exempt

No Yes

Clear

Uscan System - 09353278000007 Catalog Number :

Device Description : General ultrasound imaging system, battery-powered

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Uscan Sector Probe - Refurbished - 09353278000014 Catalog Number :

Device Description : Extracorporeal ultrasound imaging system transducer, hand-held

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Uscan Linear Probe - 09353278000021 Catalog Number :

Device Description : Extracorporeal ultrasound imaging system transducer, hand-held

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Uscan System - 09353278000038 Catalog Number :

Device Description : General ultrasound imaging system, battery-powered

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Mobile Stand - 09353278000052 Catalog Number :

Device Description : Radiological imaging system transport kit

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 1

Hub - 09353278000069 Catalog Number :

Device Description : An electronic unit that supports switching between multiple transducers, and cha An electronic unit that supports switching between multiple transducers, and charging of the display tablet and transducers.

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 1

Uscan Mobile Stand - 09353278000076 Catalog Number :

Device Description : Radiological imaging system transport kit

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 1

Uscan System (Japan) - 09353278000083 Catalog Number :

Device Description : General ultrasound imaging system, battery-powered

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

EchoNous Bladder Probe - 09353278000113 Catalog Number :

Device Description : Extracorporeal ultrasound imaging system transducer, hand-held

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Kosmos Bridge - 09353278000120 Catalog Number :

Device Description : Diagnostic ultrasound system with integrated electronic stethoscope and electroc Diagnostic ultrasound system with integrated electronic stethoscope and electrocardiographUltrasound/ electrocardiograph/ stethoscope unit

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : IYO, IYN, DQD, DPS

Prescription Use : Yes

Device Count : 1

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