Isite Pacs

• • Terminated Z-1881-2011 FDA Unclassified (pre-2012) ·initiated 23 Feb 2011 ·via K042292, on the same 510(k)

  A software anomaly that occurs when clinicians use Volume Vision to view images in 3D and uses the measurement tool to measure regions of interest. This could lead to an incorrect interpretation of the measurements which could cause an incorrect diagnosis and incorrect treatment plan.

• • Terminated Z-0118-2009 FDA Unclassified (pre-2012) ·initiated 29 Aug 2008

  Two defects have been identified: 1) potential to display a patient on the canvas page that is different from the patient whose images are displayed on diagnostic monitors when using Conference Presentation States and when opening two or more studies from a folder or an exam worklist and 2) potential to miscalculate measurements when Pixel Spacing and Imager Pixel Spacing DICOM tag values are bot

• • Terminated Z-2346-2008 FDA Unclassified (pre-2012) ·initiated 3 Jul 2008

  Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances.

• • Terminated Z-1443-2008 FDA Unclassified (pre-2012) ·initiated 29 Jan 2008

  When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a descrepancy exists in the measurement provided by the tool.

• • Terminated Z-1141-2008 FDA Unclassified (pre-2012) ·initiated 4 Jan 2008

  Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor.

• • Terminated Z-0616-2007 FDA Unclassified (pre-2012) ·initiated 14 Feb 2007

  A defect may cause patient image orientation markers to be incorrectly labeled on Multi-Planar Reformation (MPR) images. Left and Right Anatomical orientation markers may be reversed.

• • Terminated Z-0399-06 FDA Unclassified (pre-2012) ·initiated 20 Dec 2005

  When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the petient/exam selected and shown may be different on the radiologist console and diagnostic display screens

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K042292 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Stentor, Pageview

  Class I

  FDA 510(k) K992698 Active Cleared 25 Oct 1999

• iSite Radiology

  Class II

  FDA 510(k) K013630 Active Cleared 5 Dec 2001