Company:RAYSEARCH LABORATORIES AB Date of Enforcement Report 9/26/12 Class ll: PRODUCT SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT...Read More

Company:Imaging Sciences International, LLC Date of Enforcement Report 9/26/12 Class ll: PRODUCT DEXIS Imaging Suite – catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System Recall Number Z-2463-2012 REASON A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature...Read More