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510(k) K252718

Lunar Astra by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2026
Date Received
August 28, 2025
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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  • K253366 — LOGIQ Fortis (January 7, 2026)
  • K252328 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (November 24, 2025)
  • K251963 — LOGIQ E10s (October 29, 2025)
  • K251985 — LOGIQ E10 (October 29, 2025)
  • K251322 — Venue; Venue Go; Venue Fit; Venue Sprint (July 25, 2025)
  • K251342 — EchoPAC Software Only / EchoPAC Plug-in (July 16, 2025)

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)