GE Medical Systems (China) Co.,Ltd.

GE Medical Systems (China) Co.,Ltd.

Address:NO. 19 CHANGJIANG ROAD,WUXI Jiangsu,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

No Yes

Clear

Vivid - 00195278421388 Catalog Number :

Device Description : Vivid iq R6 basic console

Device Class : 2

Duns Number: 654658731

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

Vivid - 00195278422279 Catalog Number :

Device Description : T9 v206 console

Device Class : 2

Duns Number: 654658731

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

Vivid - 00195278422286 Catalog Number :

Device Description : T8 v206 console

Device Class : 2

Duns Number: 654658731

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : No

Device Count : 1

Vivid - 00195278460622 Catalog Number :

Device Description : Vivid T8 T9 v204 v205 to v206 upgrade kit

Device Class : 2

Duns Number: 654658731

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : No

Device Count : 1

Vivid - 00195278460639 Catalog Number :

Device Description : Vivid T8 T9 v204 v205 to v206 upgrade kit SW only

Device Class : 2

Duns Number: 654658731

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : No

Device Count : 1

Vivid - 00195278460677 Catalog Number :

Device Description : Vivid iq v204 to v206 upgrade kit

Device Class : 2

Duns Number: 654658731

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : No

Device Count : 1

Vivid - 00195278488527 Catalog Number :

Device Description : Vivid iq V204 to V206 SW only upgrade kit

Device Class : 2

Duns Number: 654658731

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : No

Device Count : 1

Vivid - 00195278530981 Catalog Number :

Device Description : Vivid iq v203 to v206 upgrade kit

Device Class : 2

Duns Number: 654658731

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : No

Device Count : 1

LOGIQ - 00840682102933 Catalog Number :

Device Class : 2

Duns Number: 654658731

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

LOGIQ - 00840682102940 Catalog Number :

Device Class : 2

Duns Number: 654658731

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

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