FUJIFILM HEALTHCARE CORPORATION

Address:2-1, SHINTOYOFUTA,,KASHIWA-SHI, Chiba,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

Biopsy Needle Guide Kit (OIJ) (2) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (1) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (1) Transducer, Ultrasonic, Diagnostic (ITX) (1)

Premarket Exempt

Clear

MP-2785-G23 - 04573596214312 Catalog Number :

Device Description : Needle Guide

Device Class : 2

Duns Number: 680160734

Premarket Exempt : No

Product Code : OIJ

Prescription Use : Yes

Device Count : 1

MP-2785-G25 - 04573596214329 Catalog Number :

Device Description : Needle Guide

Device Class : 2

Duns Number: 680160734

Premarket Exempt : No

Product Code : OIJ

Prescription Use : Yes

Device Count : 1

ARIETTA 650 - 04573596214381 Catalog Number :

Device Description : Diagnostic Ultrasound System

Device Class : 2

Duns Number: 680160734

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

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