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510(k) K242295

BunkerHill BMD by BunkerHill Health — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2025
Date Received
August 2, 2024
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

Other clearances by BunkerHill Health

  • K260167 — Bunkerhill Contrast AVC (March 6, 2026)
  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K250662 — Bunkerhill MAC (October 3, 2025)
  • K250649 — Bunkerhill ECG-EF (September 19, 2025)
  • K243779 — Bunkerhill Abdominal Aortic Quantification (AAQ) (July 1, 2025)
  • K243229 — Bunkerhill AVC (January 27, 2025)
  • K240369 — CAC (gated) Algorithm (September 27, 2024)

Other clearances for product code KGI

  • K251022 — 3D-SHAPER (September 5, 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)
  • K140342 — QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT (August 29, 2014)