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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 K173739
Device Name ALOKA ARIETTA 850
Applicant
Hitachi Healthcare Americas Corporation
1959 Summit Commerce Park
Twinsburg,  OH  44087
Applicant Contact Doug Thistlethwaite
Correspondent
Hitachi Healthcare Americas Corporation
1959 Summit Commerce Park
Twinsburg,  OH  44087
Correspondent Contact Doug Thistlethwaite
Regulation Number892.1550
Classification Product Code
IYN  
Date Received12/07/2017
Decision Date 02/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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