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510(k) K093714

SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM by Medison Co., Ltd. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2009
Date Received
December 2, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Medison Co., Ltd.

  • K103397 — ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM (February 25, 2011)
  • K103722 — THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM (January 5, 2011)
  • K102065 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM (August 6, 2010)
  • K101455 — EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM (July 19, 2010)
  • 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)
  • 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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