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 - 06945868695200 Catalog Number :

Device Description : X5 Pro 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 - 06945868695309 Catalog Number :

Device Description : X6 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 - 06945868695408 Catalog Number :

Device Description : X6 Exp 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 - 06945868695507 Catalog Number :

Device Description : X6 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 - 06945868696009 Catalog Number :

Device Description : S6 Diagnostic Ultrasound System

Device Class : 2

Duns Number: 545342185

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

SonoScape - 06945868696016 Catalog Number :

Device Description : S6 Diagnostic Ultrasound System (With L741 and C344 Transducers)

Device Class : 2

Duns Number: 545342185

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

SonoScape - 06945868698003 Catalog Number :

Device Description : S8 Diagnostic Ultrasound System

Device Class : 2

Duns Number: 545342185

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

SonoScape - 06945868698010 Catalog Number :

Device Description : S8 Diagnostic Ultrasound System (With C362 and L742 Transducers)

Device Class : 2

Duns Number: 545342185

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

SonoScope - 06945868699000 Catalog Number :

Device Description : S9 Portable 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 - 06945868699017 Catalog Number :

Device Description : S8 Exp Portable 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

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