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510(k) K002113

CTXA HIP; CTXA; QCT PRO CTXA HIP by Mindways Software, Inc. — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2001
Date Received
June 7, 2000
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 Mindways Software, Inc.

  • K140342 — QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT (August 29, 2014)
  • K030330 — CTXA HIP EXTENDED REFERENCE DATA (June 20, 2003)

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)