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510(k) K102065

SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM by Medison Co., Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2010
Date Received
July 23, 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

Other clearances by Medison Co., Ltd.

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  • K101829 — THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM (July 16, 2010)
  • K100186 — MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM (March 24, 2010)
  • K093849 — ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM (January 19, 2010)
  • 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)
  • K080800 — ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM (April 7, 2008)

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