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510(k) K021527

SECTRA OSTEOPOROSIS PACKAGE by Sectra-Imtec AB — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2002
Date Received
May 10, 2002
Clearance Type
Special
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 Sectra-Imtec AB

  • K040376 — SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE (May 4, 2004)
  • K033712 — MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 (December 23, 2003)
  • K031590 — SECTRA ORTHOPEDIC PACKAGE (October 2, 2003)
  • K002936 — MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM (October 17, 2000)
  • K983447 — WISE (II) IMAGE MANAGEMENT SYSTEM (October 29, 1998)
  • K965161 — SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) (March 12, 1997)
  • K963395 — IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM (October 25, 1996)
  • K961983 — TRS 2000 TELERADIOLOGY SYSTEM (August 13, 1996)

Other clearances for product code KGI

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  • 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)