SONOSCAPE MEDICAL CORP.

Address:Room 201 & 202, 12th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road, Yuehai Subdistrict,SHENZHEN Guangdong,CN

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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) (10) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (10) Transducer, Ultrasonic, Diagnostic (ITX) (10)

Premarket Exempt

Clear

SonoScape - 06945868680015 Catalog Number :

Device Description : SSI-8000 Mobile Digital Color Doppler Ultrasound System (With C362 and L743 Transducers)

Device Class : 2

Duns Number: 545342185

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

Sonoscape - 06945868691004 Catalog Number :

Device Description : E1 Exp Series Digital Color Doppler Ultrasound System

Device Class : 2

Duns Number: 545342185

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Sonoscape - 06945868691011 Catalog Number :

Device Description : E1 Pro Series Digital Color Doppler Ultrasound System

Device Class : 2

Duns Number: 545342185

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

SonoScape - 06945868691028 Catalog Number :

Device Description : X1 Digital Color Doppler Ultrasound System

Device Class : 2

Duns Number: 545342185

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

SonoScape - 06945868691035 Catalog Number :

Device Description : X1 Pro Digital Color Doppler Ultrasound System

Device Class : 2

Duns Number: 545342185

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Sonoscape - 06945868692001 Catalog Number :

Device Description : E2 Exp Series Digital Color Doppler Ultrasound System

Device Class : 2

Duns Number: 545342185

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Sonoscape - 06945868692018 Catalog Number :

Device Description : E2 Pro Series Digital Color Doppler Ultrasound System

Device Class : 2

Duns Number: 545342185

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Sonoscape - 06945868692025 Catalog Number :

Device Description : E2 Series Digital Color Doppler Ultrasound System

Device Class : 2

Duns Number: 545342185

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Sonoscape - 06945868693015 Catalog Number :

Device Description : E3 Exp Series Digital Color Doppler Ultrasound System

Device Class : 2

Duns Number: 545342185

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Sonoscape - 06945868693022 Catalog Number :

Device Description : E3 Series Digital Color Doppler Ultrasound System

Device Class : 2

Duns Number: 545342185

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

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