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510(k) K101149

GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM by Ge Vingmed Ultrasound AS — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2010
Date Received
April 23, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Ge Vingmed Ultrasound AS

  • K150087 — Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound (March 4, 2015)
  • K150085 — GE EchoPAC (March 2, 2015)
  • K141093 — 6VT-D ULTRASOUND TRANSDUCER (May 15, 2014)
  • K131685 — GE ECHOPAC (September 24, 2013)
  • K131514 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (July 12, 2013)
  • K123894 — GE ECHOPAC (January 29, 2013)
  • K120201 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (April 19, 2012)
  • K101324 — GE ECHOPAC MODEL BT10 (October 5, 2010)
  • K092756 — GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM (September 28, 2009)
  • K991842 — SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING (June 11, 1999)

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