Day

October 7, 2014
Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and...
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Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and...
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Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and...
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Company: Siemens Healthcare DiagnosticsDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be...
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Company: Siemens Healthcare DiagnosticsDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based...
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Company: Philips Medical Systems (Cleveland) IncDate of Enforcement Report: 10/7/2014 Class lI: PRODUCT The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and...
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Company: Baxter Healthcare Corp..Date of Enforcement Report:10/7/2014 Class lI: PRODUCT SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids. Recall Number Z-2738-2014 REASON One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014....
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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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