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510(k) K070813

ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM by Medison Co., Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2007
Date Received
March 26, 2007
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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  • K101829 — THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM (July 16, 2010)
  • K100186 — MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM (March 24, 2010)
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  • K093714 — SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM (December 10, 2009)
  • K092159 — ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM (July 28, 2009)
  • K081676 — SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM (July 2, 2008)

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