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510(k) K033550

DXL CALSCAN by Demetech AB — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2004
Date Received
November 12, 2003
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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  • K023028 — DEMETECH NYLON NONABSORBABLE SUTURE (June 18, 2003)
  • K023030 — DEMETECH POLYESTER NONABSORBABLE SUTURE (June 18, 2003)
  • K023029 — DEMETECH SILK NONABSORBABLE SUTURE (November 25, 2002)

Other clearances for product code KGI

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  • 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)