Isite Pacs, V 4. X

• • Terminated Z-1881-2011 FDA Unclassified (pre-2012) ·initiated 23 Feb 2011 ·on shared 510(k) K063267

  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-0948-2009 FDA Unclassified (pre-2012) ·initiated 29 Dec 2008

  Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report.

• • 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-1444-2008 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.

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

510(k) Number

K063267 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent