HITACHI, LTD.

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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) (10) Transducer, Ultrasonic, Diagnostic (ITX) (10) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (8)

Premarket Exempt

Clear

HITACHI - 04562122954785 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122954792 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122954846 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122954884 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122954891 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122954945 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122954952 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122954983 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122954990 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122955003 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

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