BEUDAMED
    9 results · 10ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult TEE; Cardiac Neonatal; Cardiac Pediatric; Cardiac Pediatric TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications

    FDA Enforcement
    Class II ·Terminated·Hitachi Aloka Medical, Ltd.·April 5, 2017

    Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

    FDA Enforcement
    Class II ·Ongoing·Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha·March 4, 2026

    Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR

    FDA Enforcement
    Class II ·Ongoing·Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha·March 4, 2026

    Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Hitachi America, Ltd., Particle Therapy Division·September 18, 2024

    Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Hitachi America, Ltd., Particle Therapy Division·September 18, 2024

    Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Hitachi America, Ltd., Particle Therapy Division·September 18, 2024

    PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    FDA Enforcement
    Class II ·Terminated·Hitachi America, Ltd., Power Systems Division·July 29, 2015

    MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Hitachi Ltd., Medical System Operations Group·May 9, 2018

    PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.

    FDA Enforcement
    Class II ·Terminated·Hitachi America, Ltd., Power Systems Division·July 3, 2019