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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K220295
Device Name ARIETTA 50
Applicant
Fujifilm Healthcare Corporation
2-1 Shintoyofuta
Kashiwa-Shi,  JP 277-0804
Applicant Contact Randy Vader
Correspondent
FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave.
Suite 300
Lexington,  MA  02421
Correspondent Contact Dennis Domoracki
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received02/02/2022
Decision Date 04/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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