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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 8 of 8 Results
510(K) Number: K121934
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TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and prec... 2 01/07/2021 Accuray Incorporated
Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is int... 2 12/26/2017 Accuray Incorporated
TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is inten... 2 12/26/2017 Accuray Incorporated
TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intende... 2 12/26/2017 Accuray Incorporated
TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intend... 2 12/26/2017 Accuray Incorporated
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5... 2 12/12/2014 TomoTherapy Incorporated
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2... 2 08/15/2014 TomoTherapy Incorporated
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0... 2 08/15/2014 TomoTherapy Incorporated
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