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510(k) K053530

SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM by Medison Co., Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2006
Date Received
December 19, 2005
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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  • K092159 — ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM (July 28, 2009)
  • K081676 — SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM (July 2, 2008)

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