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510(k) K161682

GE Lunar DXA Bone Densitometers with enCORE version 17 by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2016
Date Received
June 17, 2016
Clearance Type
Traditional
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

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Other clearances for product code KGI

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  • 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)
  • K152299 — TBS iNsight (April 29, 2016)
  • K140342 — QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT (August 29, 2014)