HITACHI, LTD.

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

Biopsy Needle Guide Kit (OIJ) (9) System, Radiation Therapy, Charged-Particle, Medical (LHN) (1)

Premarket Exempt

No

Clear

PROBEAT - 04560333350006 Catalog Number :

Device Description : The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic

Device Class : 2

Duns Number: 695377218

Premarket Exempt : No

Product Code : LHN

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122951555 Catalog Number :

Device Description : Puncture Guide Tube

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : OIJ

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122951562 Catalog Number :

Device Description : Puncture Adapter

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : OIJ

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122951616 Catalog Number :

Device Description : Puncture Guide Tube

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : OIJ

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122951630 Catalog Number :

Device Description : Puncture Guide Tube

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : OIJ

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122951647 Catalog Number :

Device Description : Puncture Guide Tube

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : OIJ

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122951654 Catalog Number :

Device Description : Puncture Guide Tube

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : OIJ

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122951661 Catalog Number :

Device Description : Puncture Guide Tube

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : OIJ

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122951678 Catalog Number :

Device Description : Puncture Guide Tube

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : OIJ

Prescription Use : Yes

Device Count : 1

HITACHI - 04562122951685 Catalog Number :

Device Description : Puncture Guide Tube

Device Class : 2

Duns Number: 693002605

Premarket Exempt : No

Product Code : OIJ

Prescription Use : Yes

Device Count : 1

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