Sectra Workstation, Version 11.1

• • Terminated Z-0412-2011 FDA Unclassified (pre-2012) ·initiated 30 Jan 2009

  Review by firm of Philips EasyVision MM workstations found that to assure compliance with 21 CFR 900.12(c)(5) corrected software was needed so that all sites are in compliance.

510(k) Number

K063093 ↗

FDA Product Code

LLZ

FDA applicant

Sectra Imtec AB

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Modification to IDS5 Image Display System

  Class II

  FDA 510(k) K002936 Active Cleared 17 Oct 2000

• Sectra IDS5 Workstation

  Class II

  FDA 510(k) K051315 Active Cleared 15 Jun 2005

• Trs 2000 Teleradiology System

  Class II

  FDA 510(k) K961983 Active Cleared 13 Aug 1996

• Sectra Microdose Mammography

  Class II

  FDA 510(k) K110025 Active Cleared 28 Apr 2011

• Imageserver 2000 Picture Archiving System

  Class I

  FDA 510(k) K963395 Active Cleared 25 Oct 1996

• Sectra IDS5 Radiology Workstation; Sectra Mpr Package; Sectra 3D Package

  Class II

  FDA 510(k) K040376 Active Cleared 4 May 2004

See all devices from Sectra-Imtec AB →