System, Imaging, Pulsed Doppler, Ultrasonic

FUJIFILM Healthcare Corporation

The following data is part of a premarket notification filed by Fujifilm Healthcare Corporation with the FDA for Arietta 50.

Pre-market Notification Details

Device IDK220295
510k NumberK220295
Device Name:ARIETTA 50
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant FUJIFILM Healthcare Corporation 2-1, Shintoyofuta Kashiwa-shi,  JP 277-0804
ContactRandy Vader
CorrespondentDennis Domoracki
FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington,  MA  02421
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-02
Decision Date2022-04-29

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