2 results
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10ms
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Sources: EU EUDAMED, US FDA
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
FDA Enforcement
Class II
·Terminated·LumiraDx·July 27, 2022
RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 3, 2015