Wise (II) Image Management System

• • Terminated Z-0695-05 FDA Unclassified (pre-2012) ·initiated 16 Feb 2005

  Failure to update correctly when re-transmitting an image from the modality.

• • Terminated Z-1125-03 FDA Unclassified (pre-2012) ·initiated 27 Jun 2003 ·on shared 510(k) K983447

  If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems.

• • Terminated Z-1223-03 FDA Unclassified (pre-2012) ·initiated 13 Feb 2002 ·on shared 510(k) K983447

  Potential display of an incorrect body part description on patient images.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K983447 ↗

FDA Product Code

LMB

Device Class

Class I

Regulation

21 CFR Part 892.2010

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 →