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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 K181376
Device Name ARIETTA 65
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  
Subsequent Product Codes
ITX   IYO  
Date Received05/24/2018
Decision Date 07/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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