GE HEALTHCARE JAPAN CORPORATION

Address:7-127, Asahigaoka 4-chome,HINO-SHI Tokyo,JP

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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, x-ray, tomography, computed (JAK) (4) DEVICE, PERCUTANEOUS, BIOPSY (MJG) (3) Transducer, ultrasonic, diagnostic (ITX) (3) System, imaging, pulsed doppler, ultrasonic (IYN) (2) System, imaging, pulsed echo, ultrasonic (IYO) (2)

Premarket Exempt

No Yes

Clear

NA - 00840682117395 Catalog Number :

Device Class : 2

Duns Number: 696021596

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

NA - 00840682119856 Catalog Number :

Device Class : 2

Duns Number: 696021596

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

NA - 00840682123860 Catalog Number :

Device Class : 2

Duns Number: 696021596

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

NA - 00840682125826 Catalog Number :

Device Class : 1

Duns Number: 696021596

Premarket Exempt : Yes

Product Code : MJG

Prescription Use : Yes

Device Count : 1

NA - 00840682125833 Catalog Number :

Device Class : 1

Duns Number: 696021596

Premarket Exempt : Yes

Product Code : MJG

Prescription Use : Yes

Device Count : 1

NA - 00840682125840 Catalog Number :

Device Class : 1

Duns Number: 696021596

Premarket Exempt : Yes

Product Code : MJG

Prescription Use : Yes

Device Count : 1

ASiR-V - 00840682134972 Catalog Number :

Device Class : 2

Duns Number: 696021596

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

MAR - 00840682134989 Catalog Number :

Device Class : 2

Duns Number: 696021596

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

Revolution - 00840682146173 Catalog Number :

Device Description : NGX Gantry common top asm with UDI

Device Class : 2

Duns Number: 696021596

Premarket Exempt : No

Product Code : JAK

Prescription Use : No

Device Count : 1

DLIR - 00840682146586 Catalog Number :

Device Class : 2

Duns Number: 696021596

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

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