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: K142100
• 510k Number: K142100
• 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: Aurelie Gruener
• Correspondent: Aurelie Gruener; SUPERSONIC IMAGINE LES JARDIN 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: 2014-08-01
• Decision Date: 2014-11-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03760193600889	K142100	000
03760193600094	K142100	000
03760193600087	K142100	000
03760193600070	K142100	000
03760193600063	K142100	000
03760193600056	K142100	000
03760193600049	K142100	000
03760193600032	K142100	000
03760193600025	K142100	000
03760193600018	K142100	000
03760193600100	K142100	000
03760193600117	K142100	000
03760193600216	K142100	000
03760193600209	K142100	000
03760193600193	K142100	000
03760193600179	K142100	000
03760193600162	K142100	000
03760193600155	K142100	000
03760193600148	K142100	000
03760193600131	K142100	000
03760193600124	K142100	000
03760193600001	K142100	000