AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems

System, Imaging, Pulsed Doppler, Ultrasonic

Supersonic Imagine

The following data is part of a premarket notification filed by Supersonic Imagine with the FDA for Aixplorer® & Aixplorer® Ultimate Ultrasound Systems.

Pre-market Notification Details

• Device ID: K171105
• 510k Number: K171105
• Device Name: AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: Supersonic Imagine Les Jardins De La Duranne - Bat E&F - 510 Rue Rene Descartes Aix-en-provence, FR 13857
• Contact: Laurence Hermitte
• Correspondent: Laurence Hermitte; Supersonic Imagine Les Jardins De La Duranne - Bat E&F - 510 Rue Rene Descartes Aix-en-provence, FR 13857
• Product Code: IYN
• Subsequent Product Code: ITX
• Subsequent Product Code: IYO
• CFR Regulation Number: 892.1550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-13
• Decision Date: 2017-07-11
• Summary: summary