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: K161999
• 510k Number: K161999
• Device Name: Aixplorer
• 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: Jacques Souquet; 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: 2016-07-20
• Decision Date: 2016-11-16
• Summary: summary