HAMAMATSU PHOTONICS K.K.

Address:812 JOKO-CHO,HAMAMATSU CITY Shizuoka,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

Confocal Optical Imaging (OWN) (3) System, X-Ray, Angiographic (IZI) (2) Oximeter (DQA) (1) Oximeter, Tissue Saturation (MUD) (1) Whole Slide Imaging System (PSY) (1)

Premarket Exempt

Clear

PDE - 04582389010031 Catalog Number :

Device Class : 2

Duns Number: 704524537

Premarket Exempt : No

Product Code : OWN

Prescription Use : Yes

Device Count : 1

NIRO-200NX - 04582389010062 Catalog Number :

Device Class : 2

Duns Number: 704524537

Premarket Exempt : No

Product Code : MUD, DQA

Prescription Use : Yes

Device Count : 1

pde-neo - 04582389010093 Catalog Number :

Device Class : 2

Duns Number: 704524537

Premarket Exempt : No

Product Code : OWN, IZI

Prescription Use : Yes

Device Count : 1

pde-neoII - 04582389010543 Catalog Number :

Device Class : 2

Duns Number: 704524537

Premarket Exempt : No

Product Code : IZI, OWN

Prescription Use : Yes

Device Count : 1

NanoZoomer S360MD Slide scanner system - 04582389010659 Catalog Number :

Device Class : 2

Duns Number: 704524537

Premarket Exempt : No

Product Code : PSY

Prescription Use : Yes

Device Count : 1

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