August 19, 2020
Company: Shanghai United Imaging Healthcare Co., Ltd. Date of Enforcement Report: 8/19/2020 Class II PRODUCT uEXPLORER PET/CT Diagnostic Imaging System – Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but...
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Company: Ion Beam Applications S.A. Date of Enforcement Report: 8/19/2020 Class II PRODUCT Proteus 235 The Proton Therapy System – Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment...
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Company: NeuroLogica Corporation Date of Enforcement Report: 8/19/2020 Class II PRODUCT OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 – Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck. Recall...
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Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

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