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510(k) K220402

VirtuOst by O.N. Diagnostics — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2023
Date Received
February 11, 2022
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 O.N. Diagnostics

  • K171435 — VirtuOst Vertebral Fracture Assessment (August 3, 2018)
  • K113725 — VIRTUOST (September 13, 2012)

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)
  • 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)