SUPERSONIC IMAGINE, INC.

SUPERSONIC IMAGINE, INC.

Address:Zac de l enfant,Aix-en-Provence Bouches-du-Rhone,FR

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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) (1) System, imaging, pulsed echo, ultrasonic (IYO) (1)

Premarket Exempt

No

Clear

SL15-4 Gen I® - 03760193600001 Catalog Number : SSIP90002

Device Description : Linear Probe SL15-4 Gen I®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

Aixplorer® - 03760193600018 Catalog Number : SSIP92029

Device Description : Imaging Ultrasound Diagnostic System

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : IYO, IYN

Prescription Use : No

Device Count : 1

SL15-4 Gen II® - 03760193600025 Catalog Number : SSIP92002

Device Description : Linear Probe SL15-4 Gen II®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

SC6-1 Gen II® - 03760193600032 Catalog Number : SSIP92030

Device Description : Curved Probe SC6-1 Gen II®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

SLV16-5 Gen II® - 03760193600049 Catalog Number : SSIP92055

Device Description : 3D Probe SLV16-5 Gen II®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

SE12-3 Gen II® - 03760193600056 Catalog Number : SSIP92068

Device Description : Endo Probe SE12-3 Gen II®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

SL10-2 Gen II® - 03760193600063 Catalog Number : SSIP92085

Device Description : Linear Probe SL10-2 Gen II®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

SMC12-3 Gen II® - 03760193600070 Catalog Number : SSIP92097

Device Description : Mircoconvex Probe SMC12-3 Gen II®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

XP5-1® - 03760193600087 Catalog Number : SSIP92161

Device Description : Phased array Probe XP5-1®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

SLH20-6® - 03760193600094 Catalog Number : SSIP92164

Device Description : Hockey-Stick Probe SLH20-6®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

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