FUJIFILM CORPORATION

Address:798 MIYANODAI KAISEI-MACHI,ASHIGARAKAMI-GUN Kanagawa,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

Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (2) ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE (MNL) (1) Adaptor, Bulbs, Miscellaneous, For Endoscope (FFY) (1) Adaptor, bulbs, miscellaneous, for endoscope (FFY) (1) Interventional Fluoroscopic X-Ray System (OWB) (1) System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (1)

Premarket Exempt

No Yes

Clear

Wired foot switch - 04547410480832 Catalog Number :

Device Description : A foot switch with a cable to connect to DR-XD 3000FX.

Device Class : 2

Duns Number: 713565195

Premarket Exempt : No

Product Code : OWB, JAA

Prescription Use : No

Device Count : 1

D-EVOIII G80i - 04547410483420 Catalog Number :

Device Description : The DR-ID 1836SE incorporate a GOS indirect panel. The indirect-conversion flat

Device Class : 2

Duns Number: 713565195

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

Protective Cover - 04547410483437 Catalog Number :

Device Description : Protective cover is placed on a flat panel sensor (DR-ID 1836SE) during recumben

Device Class : 2

Duns Number: 713565195

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

FUJIFILM - 24547410095580 Catalog Number :

Device Description : This product is exclusively used for manual cleaning and manual disinfection of

Device Class : 1

Duns Number: 713565195

Premarket Exempt : Yes

Product Code : FFY

Prescription Use : Yes

Device Count : 1

FUJIFILM - 24547410438677 Catalog Number :

Device Description : This product is exclusively used for manual cleaning and manual disinfection of

Device Class : 1

Duns Number: 713565195

Premarket Exempt : No

Product Code : FFY

Prescription Use : Yes

Device Count : 1

FUJIFILM - 34547410435246 Catalog Number :

Device Description : This product is intended to clean the instrument/suction channel and accessories

Device Class : 1

Duns Number: 713565195

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

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