FDA 510(k) Applications Submitted by Hitachi Healthcare Americas

FDA 510(k) Number Submission Date Device Name Applicant
K190248 02/07/2019 ARIETTA 50 Hitachi Healthcare Americas
K200498 02/28/2020 SCENARIA View Hitachi Healthcare Americas
K190841 04/01/2019 SCENARIA View Hitachi Healthcare Americas
K211406 05/06/2021 OASIS MRI System Hitachi Healthcare Americas
K191233 05/08/2019 ARIETTA 750 Hitachi Healthcare Americas
K202030 07/22/2020 OASIS MRI System Hitachi Healthcare Americas
K202422 08/24/2020 Arietta 65 Hitachi Healthcare Americas
K192851 10/03/2019 OASIS MRI System Hitachi Healthcare Americas
K180901 04/06/2018 Low Dose CT Lung Cancer Screening Option Hitachi Healthcare Americas
K172492 08/17/2017 Optical Topography System ETG-4100 Hitachi Healthcare Americas
K183291 11/26/2018 Supria True64 Whole-Body X-Ray CT System Hitachi Healthcare Americas
K183456 12/13/2018 Aloka Arietta 850 Hitachi Healthcare Americas


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