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510(k) K071570

GE LUNAR BODY COMPOSITION SOFTWARE by Ge Medical Systems Lunar — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2007
Date Received
June 8, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Lunar

  • K113286 — ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS (April 27, 2012)

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  • 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)