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510(k) K103397

ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM by Medison Co., Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2011
Date Received
November 19, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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  • K081676 — SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM (July 2, 2008)
  • K080800 — ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM (April 7, 2008)

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