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510(k) K052581

LUNAR IDXA by Ge Medical Systems Ultrasound and Primary Care Dia — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2005
Date Received
September 20, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Densitometer, Bone
Device Class
Class II
Regulation Number
892.1170
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)
  • K082185 — GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 (August 15, 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)
  • K041813 — GE LOGIQ 7 ULTRASOUND BT04 (July 23, 2004)

Other clearances for product code KGI

  • K251022 — 3D-SHAPER (September 5, 2025)
  • K242295 — BunkerHill BMD (April 8, 2025)
  • K243218 — TBS iNsight (V4) (January 17, 2025)
  • K220402 — VirtuOst (May 19, 2023)
  • K220822 — 3D-SHAPER (December 9, 2022)
  • K213760 — ABMD Software (July 29, 2022)
  • K191112 — GEHC DXA Bone Densitometers with enCORE version 18 (September 19, 2019)
  • K180782 — Aria (April 20, 2018)
  • K161682 — GE Lunar DXA Bone Densitometers with enCORE version 17 (December 2, 2016)
  • K152299 — TBS iNsight (April 29, 2016)