AIXPLORER

Transducer, Ultrasonic, Diagnostic

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: K102041
• 510k Number: K102041
• Device Name: AIXPLORER
• Classification: Transducer, Ultrasonic, Diagnostic
• Applicant: SUPERSONIC IMAGINE 510 RUE RENE DESCARTES Aix-en-provence Cedex, FR 13857
• Contact: Jacques Souquet
• Correspondent: Jacques Souquet; SUPERSONIC IMAGINE 510 RUE RENE DESCARTES Aix-en-provence Cedex, FR 13857
• Product Code: ITX
• Subsequent Product Code: IYN
• Subsequent Product Code: IYO
• CFR Regulation Number: 892.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-07-19
• Decision Date: 2010-10-13
• Summary: summary