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

System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (9) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (8) Transducer, Ultrasonic, Diagnostic (ITX) (1)

Premarket Exempt

Clear

Ultrasonix Medical Corporation - 08294360350840 Catalog Number :

Device Description : SA4-2/24 Phased Array Transducer

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294361800009 Catalog Number :

Device Description : SonixTOUCH Ultrasound System

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : IYN, IYO

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294361800023 Catalog Number :

Device Description : SonixTOUCH Q+ Ultrasound System

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : IYN, IYO

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294362000002 Catalog Number :

Device Description : SonixMDP Ultrasound System

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : IYN, IYO

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294362000026 Catalog Number :

Device Description : SonixMDP Q+ Ultrasound System

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : IYN, IYO

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294362100009 Catalog Number :

Device Description : SonixOP Ultrasound System

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : IYO, IYN

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294362100023 Catalog Number :

Device Description : SonixOP Q+ Ultrasound System

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : IYN, IYO

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294362200006 Catalog Number :

Device Description : SonixSP Ultrasound System

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : IYN, IYO

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294362200020 Catalog Number :

Device Description : SonixSP Q+Ultrasound System

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : IYN, IYO

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294362400000 Catalog Number :

Device Description : SonixTABLET Ultrasound System

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : IYN

Prescription Use : Yes

Device Count : 1

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