Company:QRS Diagnostic. Date of Enforcement Report 4/4/12 Class ll: PRODUCT QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400. Product Usage: The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to...Read More

Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 4/4/12 Class ll: PRODUCT MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System. Product Usage: Medical charged particle radiation therapy system. The intended use of the SIEMENS branded PRIMUS, ONCOR and...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 4/4/12 Class ll: PRODUCT The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System. The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray...Read More