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510(k) K093466

HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS by Hitachi Medical Systems America, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2010
Date Received
November 6, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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