Shantou Institute of Ultrasonic Instruments Co., Ltd.

Address:77 JINSHA RD.,SHANTOU 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 Echo, Ultrasonic (IYO) (8) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (5) Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (2) System, Image Processing, Radiological (LLZ) (2) System, X-Ray, Mobile (IZL) (2)

Premarket Exempt

No Yes

Clear

SIUI - 06938396400576 Catalog Number :

Device Description : Digital Color Doppler Ultrasound Imaging System

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IYN, IYO

Prescription Use : Yes

Device Count : 1

SIUI - 06938396400811 Catalog Number :

Device Description : Digital Color Doppler Ultrasound Imaging System

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IYO, IYN

Prescription Use : Yes

Device Count : 1

SIUI - 06938396404154 Catalog Number :

Device Description : Ultrasound Imaging System

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

SIUI - 06938396404857 Catalog Number :

Device Description : Ultrasound Imaging System

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

SIUI - 06938396409005 Catalog Number :

Device Description : Digital Ultrasound Imaging System

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

SIUI - 06938396410001 Catalog Number :

Device Description : Digital Color Doppler Ultrasound Imaging System

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IYN, IYO

Prescription Use : Yes

Device Count : 1

SIUI - 06938396410049 Catalog Number :

Device Description : Portable DR Imaging System

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IZL, MQB, LLZ

Prescription Use : Yes

Device Count : 1

SIUI - 06938396410056 Catalog Number :

Device Description : Digital Color Doppler Ultrasound Imaging System

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IYN, IYO

Prescription Use : Yes

Device Count : 1

SIUI - 06938396410063 Catalog Number :

Device Description : Portable DR Imaging System

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IZL, MQB, LLZ

Prescription Use : Yes

Device Count : 1

SIUI - 06938396410070 Catalog Number :

Device Description : Digital Color Doppler Ultrasound Imaging System

Device Class : 2

Duns Number: 654090299

Premarket Exempt : No

Product Code : IYN, IYO

Prescription Use : Yes

Device Count : 1

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