FUJIFILM SONOSITE, INC.

FUJIFILM SONOSITE, INC.

Address:21919 30th Dr SE,BOTHELL,WA,98021,US

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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) (10) System, imaging, pulsed echo, ultrasonic (IYO) (10) Transducer, ultrasonic, diagnostic (ITX) (10)

Premarket Exempt

No

Clear

Edge Stand - 00841517100025 Catalog Number : P15800

Device Description : Diagnostic Ultrasound System Accessory

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

SonoSite M-Turbo - 00841517100032 Catalog Number :

Device Description : Diagnostic ultrasound system

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

C11x/8-5 MHz - 00841517100056 Catalog Number :

Device Description : Diagnostic Ultrasound Transducer

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

V-Universal Stand - 00841517100063 Catalog Number :

Device Description : Diagnostic Ultrasound System Accessory

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

H-Universal Stand - 00841517100070 Catalog Number :

Device Description : Diagnostic Ultrasound System Accessory

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Power Park - 00841517100087 Catalog Number :

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

Power Park - 00841517100094 Catalog Number :

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

Power Pack - 00841517100100 Catalog Number : P13122

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Edge Mini-Dock - 00841517100117 Catalog Number :

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

SII Stand - 00841517100124 Catalog Number :

Device Description : Ultrasound System Accessory

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

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