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510(k) K082185

GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 by Ge Medical Systems Ultrasound and Primary Care Dia — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2008
Date Received
August 1, 2008
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 Medical Systems Ultrasound and Primary Care Dia

  • K103730 — GE LUNAR VISCERAL FAT SOFTWARE (May 6, 2011)
  • K072664 — GE LUNAR FEMUR STRENGTH SOFTWARE (November 21, 2008)
  • K073408 — GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM (December 19, 2007)
  • K072439 — GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT (September 14, 2007)
  • K052581 — LUNAR IDXA (October 20, 2005)
  • K041813 — GE LOGIQ 7 ULTRASOUND BT04 (July 23, 2004)

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