FDA 510(k) Applications Submitted by Janine Reyes

FDA 510(k) Number Submission Date Device Name Applicant
K150427 02/19/2015 Vantage Titan 1.5T, V3.1, MRT-1510 TOSHIBA MEDICAL SYSTEMS CORPORATION
K152371 08/21/2015 Vantage Titan 3T Toshiba Medical Systems Corporation
K152697 09/21/2015 INFX-8000C, V6.20 TOSHIBA MEDICAL SYSTEMS CORPORATION
K230355 02/09/2023 Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K222387 08/08/2022 Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K222968 09/27/2022 Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K203553 12/04/2020 Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K210164 01/21/2021 Vantage Elan 1.5T, MRT-2020, V6.0 Canon Medical Systems Corporation
K211633 05/27/2021 Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K212056 07/01/2021 Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K213305 10/04/2021 Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation
K203323 11/12/2020 Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation


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