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

System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (7) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (7) Transducer, Ultrasonic, Diagnostic (ITX) (7) Biopsy Needle Guide Kit (OIJ) (3)

Premarket Exempt

Clear

EZU-PA5O-14 - 04573596210925 Catalog Number :

Device Description : Biopsy Attachment

Device Class : 2

Duns Number: 680160734

Premarket Exempt : No

Product Code : OIJ

Prescription Use : Yes

Device Count : 1

EZU-PA5O-18 - 04573596210932 Catalog Number :

Device Description : Biopsy Attachment

Device Class : 2

Duns Number: 680160734

Premarket Exempt : No

Product Code : OIJ

Prescription Use : Yes

Device Count : 1

EZU-PA5O-21 - 04573596210949 Catalog Number :

Device Description : Biopsy Attachment

Device Class : 2

Duns Number: 680160734

Premarket Exempt : No

Product Code : OIJ

Prescription Use : Yes

Device Count : 1

C22I - 04573596211267 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 680160734

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

C22K - 04573596211274 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 680160734

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

C22P - 04573596211281 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 680160734

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

C22T - 04573596211298 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 680160734

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

C23RV - 04573596211304 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 680160734

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

C23 - 04573596211311 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 680160734

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

C25 - 04573596211328 Catalog Number :

Device Description : Probe

Device Class : 2

Duns Number: 680160734

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

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