2 results
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96ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS 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 by radiation.
FDA Enforcement
Class II
·Terminated·Hitachi America, Ltd., Power Systems Division·July 29, 2015
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
FDA Enforcement
Class II
·Terminated·Hitachi America, Ltd., Power Systems Division·July 3, 2019