Company:Volcano Corp. Date of Enforcement Report 2/15/12 Class ll: PRODUCT Volcano pcFM Software Kit. The volcano pcFM Software Kit is a research only off line tool intended for review and printout of physiological measurements recorded by ComboMap System. It is not intended for analysis or manipulation of the original measurement data. Model 6830 ComboMap Software...Read More

Company:Philips Medical Systems Date of Enforcement Report 2/15/12 Class ll: PRODUCT Pinnacle3 Radiation Therapy Planning System, software version 9.0. Model # Description 453560446041 Pinnacle3 version 9.0 English 453560446051 Pinnacle3 version 9.0 Simplified Chinese 453560446061 Pinnacle3 version 9.0 Traditional Chinese 453560446091 Pinnacle3 version 9.0 Dutch 453560446101 Pinnacle3 version 9.0 French 453560446111 Pinnacle3 version 9.0 German 453560446141...Read More

Company:Philips Medical Systems Date of Enforcement Report 2/15/12 Class ll: PRODUCT GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), a) Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 3.5.1.1), b) Model #882471. The device is a diagnostic imaging system for fixed or mobile installations that combines...Read More