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 echo, ultrasonic (IYO) (1)

Premarket Exempt

Clear

SE12-3 Gen III® - 03760193600209 Catalog Number : SSIP93068

Device Description : Endo Transducer SE12-3 Gen III®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

SLV16-5 Gen III® - 03760193600216 Catalog Number : SSIP93055

Device Description : 3D Transducer SLV16-5 Gen III®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

Aixplorer® Ultimate - 03760193600889 Catalog Number :

Device Description : Imaging Ultrasound Diagnostic System

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 1

LH20-6® - 03760193601114 Catalog Number : 3760193601114

Device Description : Hockey-Stick Probe LH20-6®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

P5-1X® - 03760193601213 Catalog Number : SSIP95107

Device Description : Phased array Probe P5-1X®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

C9-2X® - 03760193601244 Catalog Number : 3760193601244

Device Description : Curved Probe C9-2X®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

MC12-3® - 03760193601312 Catalog Number : 3760193601312

Device Description : Mircoconvex Probe MC12-3®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

E12-3® - 03760193601350 Catalog Number : 3760193601350

Device Description : Endo Probe E12-3®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

C6-1X® - 03760193601411 Catalog Number : 3760193601411

Device Description : Curved Probe C6-1X®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

L18-5® - 03760193601527 Catalog Number : 3760193601527

Device Description : Linear Probe L18-5®

Device Class : 2

Duns Number: 034094134

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

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