BEUDAMED
    58 results · 34ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·April 24, 2013

    3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.

    FDA Enforcement
    Class II ·Terminated·NeoCoil, LLC·August 10, 2016

    Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·May 4, 2016

    Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·November 20, 2013

    Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·October 12, 2016

    Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·October 12, 2016

    Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·July 27, 2016

    Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·October 12, 2016

    Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast-enhanced studies, nonvascular IVR, vascular contrast-enhanced studies support of vascular NR, and general radiography.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·September 6, 2017

    TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·March 12, 2014

    Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·October 12, 2016

    Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D images) of the whole human body (including the head). The CT images provide morphological information showing the positional relationships between the lesion and adjacent tissues, while the PET images provide functional information based on the uptake of the injected radioisotope.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·May 11, 2016

    Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·October 25, 2017

    Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and trans mission/ output of images to external devices.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems·September 20, 2017

    Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·August 24, 2016

    Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·November 30, 2016

    XARIO 200 TUS-X200 diagnostic ultrasound system

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·July 19, 2017

    Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·November 6, 2013

    Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstruction!;, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·September 5, 2012

    Toshiba Aquilion CT System TSX-301B

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·October 21, 2015