GE Vingmed Ultrasound AS

GE Vingmed Ultrasound AS

Address:STRANDPROMENADEN 45,HORTEN Vestfold,NO

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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) (8) System, imaging, pulsed echo, ultrasonic (IYO) (8) Transducer, ultrasonic, diagnostic (ITX) (8) Automated Radiological Image Processing Software (QIH) (2) System, image processing, radiological (LLZ) (2)

Premarket Exempt

No

Clear

Vivid - 00195278276261 Catalog Number :

Device Description : Vivid S60N v205CH

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : No

Device Count : 1

Vivid - 00195278276278 Catalog Number :

Device Description : Vivid S70N v205 China

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Vivid - 00195278276285 Catalog Number :

Device Description : Vivid S70N v205 NOR

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : No

Device Count : 1

Vivid - 00195278276322 Catalog Number :

Device Description : Vivid S60N v205 NOR

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

Vivid - 00195278341235 Catalog Number :

Device Description : Preown Vivid E95 R4 LCD

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : No

Device Count : 1

NA - 00195278388483 Catalog Number : KN100130

Device Description : 9VT-D Probe

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : No

Device Count : 1

Vivid - 00195278406866 Catalog Number :

Device Description : Vivid S70N S60N v204 to v205 Upg kit

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Vivid - 00195278435743 Catalog Number :

Device Description : Vivid E v204 4D ICE UPG

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : No

Device Count : 1

EchoPAC - 00195278504302 Catalog Number :

Device Description : MD EchoPAC Software Only v206

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : QIH, LLZ

Prescription Use : No

Device Count : 1

EchoPAC - 00195278504326 Catalog Number :

Device Description : MD EchoPAC Plug-in v206

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : QIH, LLZ

Prescription Use : No

Device Count : 1

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