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) (6) System, X-Ray, Tomography, Computed (JAK) (3) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (1)

Premarket Exempt

Clear

Analogic ImpaCT - 00814277020155 Catalog Number :

Device Description : Analogic ImpaCT 16-slice

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

Analogic ImpaCT - 00814277020162 Catalog Number :

Device Description : Analogic ImpaCT 64-slice

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

Analogic ImpaCT - 00814277020308 Catalog Number :

Device Description : Analogic ImpaCT 128-slice Analogic ImpaCT 128-slice

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294360246341 Catalog Number :

Device Description : SonixONE Cart

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : IYN

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294360350352 Catalog Number :

Device Description : Linear Wide Transducer for - Abdominal, Musculoskeletal, Nerve Block, Pediatric Linear Wide Transducer for - Abdominal, Musculoskeletal, Nerve Block, Pediatric and Small Parts

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294360350499 Catalog Number :

Device Description : EC9-5/10 Endocavity Microconvex Transducer

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294360350536 Catalog Number :

Device Description : BPC8-4/10 Microconvex BPL9-5/55 Linear Biplane Transducer

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294360350567 Catalog Number :

Device Description : HST 15-8/20, Linear Transducer

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294360350581 Catalog Number :

Device Description : MC9-4 Microconvex transducer

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Ultrasonix Medical Corporation - 08294360350604 Catalog Number :

Device Description : 4DEC9-5/10, 4D motor-driven electronic Endocavity Microconvex Transducer

Device Class : 2

Duns Number: 019677418

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

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