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 echo, ultrasonic (IYO) (10) Transducer, ultrasonic, diagnostic (ITX) (10) System, imaging, pulsed doppler, ultrasonic (IYN) (8)

Premarket Exempt

Clear

Triple Transducer Connect - 00841517100131 Catalog Number :

Device Description : Diagnostic Ultrasound System Accessory

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

Triple Transducer Connect - 00841517100148 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

AxoTrack I Sterile Procedure Kit - 00841517100155 Catalog Number : P22506

Device Description : Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x ultrasound transducer.

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

AxoTrack I Sterile Procedure Kit - 00841517100162 Catalog Number : P22508

Device Class :

Duns Number: 014438860

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

Triple Transducer Connect - 00841517100179 Catalog Number :

Device Description : Diagnostic Ultrasound System Accessory

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Triple Transducer Connect - 00841517100186 Catalog Number :

Device Description : Diagnostic Ultrasound System Accessory

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Triple Transducer Connect - 00841517100193 Catalog Number :

Device Description : Diagnostic Ultrasound System Accessory

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

M-Turbo Mini-Dock - 00841517100209 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

SonoSite SII - 00841517100216 Catalog Number :

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

SonoSite Edge II - 00841517100223 Catalog Number :

Device Description : Diagnostic ultrasound system

Device Class : 2

Duns Number: 014438860

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

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