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510(k) K091325

TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS by Cooper Surgical — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2009
Date Received
May 5, 2009
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

  • 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)