Day

September 12, 2012
Company:Trek Diagnostic Systems Date of Enforcement Report 9/12/12 Class lll: PRODUCT VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and...
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http://lms.ulknowledgeservices.com/catalog/display.resource.aspx?resourceid=411809
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Company:RAYSEARCH LABORATORIES AB Date of Enforcement Report 9/12/12 Class ll: PRODUCT Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters...
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Company:Capintec Inc. Date of Enforcement Report 9/12/12 Class ll: PRODUCT Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity. Recall Number Z-2312-2012 REASON Customers who received a Capintec Captus 3000...
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SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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