3 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MR, or X-ray.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·July 18, 2012
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·June 10, 2015
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines.
FDA Enforcement
Class II
·Terminated·Sysmex America, Inc.·April 22, 2020