5 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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OASIS MRI System
FDA Enforcement
Class II
·Terminated·Hitachi Healthcare Americas Corporation·September 1, 2021
ECHELON Oval MRI System
FDA Enforcement
Class II
·Terminated·Hitachi Healthcare Americas Corporation·September 1, 2021
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
FDA Enforcement
Class II
·Ongoing·Hitachi Healthcare Americas Corporation·August 25, 2021
ECHELON MRI System
FDA Enforcement
Class II
·Terminated·Hitachi Healthcare Americas Corporation·September 1, 2021
VidiStar(TM) PACS & DICOM Viewer Software system
FDA Enforcement
Class II
·Terminated·Hitachi Healthcare Americas Corp Informatics Division·September 12, 2018