Company: TomoTherapy, IncDate of Enforcement Report 1/28/2009 Class:ll PRODUCT TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. TomoTherapy HI-ART Systems is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy...Read More

CompanyGE Medical SystemsDate of Enforcement Report 1/28/2009 Class:ll PRODUCT a) GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System. The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic...Read More