BEUDAMED
    17 results · 84ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement ×

    Hitachi Echelon MRI System

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·March 29, 2017

    Hitachi Oasis MRI System

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·March 29, 2017

    Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·May 24, 2017

    Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·August 17, 2016

    Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR systems produce transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities.

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·June 26, 2013

    Hitachi Echelon Oval MRI System

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·March 29, 2017

    Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the head, body, or extremities. The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·July 25, 2018

    Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·July 25, 2012

    UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·February 26, 2020

    Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·September 10, 2014

    Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the SCENARIA can be post processed by the SCENARIA to provide additional information. Post processing capabilities included in the SCENARIA software include CT angiography (CTA), Multiplanar reconstruction (MPR) and volume rendering. Volume datasets acquired by the SCENARIA Phase 3 can be transferred to external devices via a DICOM standard interface. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·August 29, 2018

    Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination.

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·August 29, 2012

    Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·March 7, 2018

    Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. The Coil Extension Cable that is the subject of the removal action is an accessory that is used in conjunction with certain anatomy coils to aid in patient positioning.

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·August 19, 2015

    Hitachi Oasis MRI System - C-Spine Coil

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·February 1, 2017

    Hitachi Scenaria Whole-body X-ray CT System

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·November 13, 2019

    Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, Endoscopy clinical applications.

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·March 31, 2021