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FDA 510(k) Applications Submitted by Hitachi Aloka Medical America, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K142618
09/16/2014
Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System
Hitachi Aloka Medical America, Inc.
K153421
11/25/2015
HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS
HITACHI ALOKA MEDICAL AMERICA, INC.
K152126
07/31/2015
UST-5550-R; UST-5536-R; L43K
HITACHI ALOKA MEDICAL AMERICA, INC.
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