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510(k) K102901

HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER by Hitachi Medical Systems America, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2010
Date Received
September 30, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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