June 7, 2012
Company:Computerized Medical Systems Inc.Date of Enforcement Report 6/6/12 Class ll: PRODUCT XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within...
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Company:Ortho-Clinical Diagnostics.Date of Enforcement Report 6/6/12 Class ll: PRODUCT VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Product...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/6/12 Class ll: PRODUCT 1) Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compounding feature Software Versions 3.0, 3.0A and 3.1. (VB20, VB20A, and VB21A); Model #: 10041461 – ACUSON S2000 Mainframe; The ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnostic...
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Company:Becton Dickinson & Co..Date of Enforcement Report 6/6/12 Class ll: PRODUCT 1) Becton Dickinson Phoenix” System Software, catalog # 448035/448046, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: Automated Microbiology System for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram...
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