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510(k) K213760

ABMD Software by HeartLung Corporation — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2022
Date Received
December 1, 2021
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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  • K220402 — VirtuOst (May 19, 2023)
  • K220822 — 3D-SHAPER (December 9, 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)
  • K140342 — QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT (August 29, 2014)