ANALOGIC CORPORATION

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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

Transducer, Ultrasonic, Diagnostic (ITX) (9) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (4) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (3)

Premarket Exempt

Clear

Ultrasonix Medical Corporation - 08294362400024 Catalog Number :

Device Description : SonixONE Ultrasound System

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : IYN

Prescription Use : Yes

Device Count : 1

Sonic Window Handheld Ultrasound System - 90814277020004 Catalog Number :

Device Description : The Sonic Window is intended for the visualization of vessels and vascular acces The Sonic Window is intended for the visualization of vessels and vascular access guidance of needles and catheters (Insertion of Peripheral Intra Venous (PIV) Catheters, as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only.

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Sonic Window Docking Station - 90814277020011 Catalog Number :

Device Description : Docking Station for Sonic Window Handheld Ultrasound System

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Sonic Window Handheld Ultrasound Unit - 90814277020028 Catalog Number :

Device Description : Replacement unit for Sonic Window Handheld Ultrasound System

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Pathfinder Shadow BK-T - 90814277020035 Catalog Number :

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Pathfinder Shadow - 90814277020042 Catalog Number :

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Pathfinder Shadow (Aloka) - 90814277020059 Catalog Number :

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Pathfinder Small Multi-Tool Instrument Clamp - 90814277020066 Catalog Number :

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Pathfinder Large Multi-Tool Instrument Clamp - 90814277020073 Catalog Number :

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Pathfinder Beacon - 90814277020080 Catalog Number :

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

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