AIXPLORER

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.

Pre-market Notification Details

• Device ID: K112255
• 510k Number: K112255
• Device Name: AIXPLORER
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: SUPERSONIC IMAGINE 510. RUE RENE DESCARTES BAT. E ET F Aix En Provence, FR 13857
• Contact: Jacques Souquet
• Correspondent: Jacques Souquet; SUPERSONIC IMAGINE 510. RUE RENE DESCARTES BAT. E ET F 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: 2011-08-05
• Decision Date: 2012-08-28
• Summary: summary