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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 K160559
Device Name NOBLUS™ Ultrasound Diagnostic System
Applicant
Hitachi Medical Corporation
10 Fairfield Blvd.
Wallingford,  CT  06492 -7502
Applicant Contact ANGELA VAN ARSDALE
Correspondent
Hitachi Medical Corporation
10 Fairfield Blvd.
Wallingford,  CT  06492 -7502
Correspondent Contact ANGELA VAN ARSDALE
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received02/29/2016
Decision Date 10/18/2016
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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