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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K152126
Device Name UST-5550-R; UST-5536-R; L43K
Applicant
Hitachi Aloka Medical America, Inc.
10 Fairfield Blvd.
Wallingford,  CT  06492
Applicant Contact ANGELA VAN ARSDALE
Correspondent
Hitachi Aloka Medical America, Inc.
10 Fairfield Blvd.
Wallingford,  CT  06492
Correspondent Contact ANGELA VAN ARSDALE
Regulation Number892.1570
Classification Product Code
ITX  
Date Received07/31/2015
Decision Date 08/17/2016
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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