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510(k) K040376

SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE by Sectra-Imtec AB — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2004
Date Received
February 17, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Sectra-Imtec AB

  • K033712 — MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 (December 23, 2003)
  • K031590 — SECTRA ORTHOPEDIC PACKAGE (October 2, 2003)
  • K021527 — SECTRA OSTEOPOROSIS PACKAGE (June 7, 2002)
  • 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)

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