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 IDK142100
510k NumberK142100
Device Name:AIXPLORER
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SUPERSONIC IMAGINE Les Jardins De La Duranne Bat. E & F, 510 RUE RENE DESCARTES Aix-en-provence,  FR 13857
ContactAurelie Gruener
CorrespondentAurelie Gruener
SUPERSONIC IMAGINE LES JARDIN DE LA DURANNE-BAT. E & F 510 RUE RENE DESCARTES Aix-en-provence,  FR 13857
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-01
Decision Date2014-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

Trademark Results [AIXPLORER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AIXPLORER
AIXPLORER
85200839 4089887 Live/Registered
SuperSonic Imagine
2010-12-17

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