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    IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·April 4, 2018

    IMRIS T2X Table, Part Number 109682-600

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·March 21, 2018

    IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·December 26, 2018

    IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·December 26, 2018

    IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·December 26, 2018

    IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·April 4, 2018

    IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·April 4, 2018

    IMRIS ORT100 Table, Part Number 110470-000

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·March 21, 2018

    IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·April 4, 2018

    IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·April 4, 2018

    IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·April 4, 2018

    IMRIS MR/X-ray head fixation device, Model HFD200

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·October 30, 2019

    IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·December 26, 2018

    IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·May 16, 2018

    iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The IMRIS iMRX system is the integration of a Siemens Artis zee family (biplane or floor or ceiling mounted single plane) and the IMRIS Neuro 3T System. The System is a solution providing MRI scanning capabilities in the angiography room while retaining all functionality of Siemens Artis zee system. The System includes a traditional MRI unit that has been suspended on an overhead rail system, and is designed to operate inside RF room to facilitate intra-operative, interventional, and multi-room imaging. It also allows intra-operative or interventional imaging capabilities, while retaining all diagnostic functionality of a standard MRI system in the diagnostic room. The iMRX system allows for the sequential use of either MR imaging or X-ray fluoroscopic imaging of the head or chest for a single patient while positioned on a common fixed table either prior to, during or post clinical procedure. When these images are interpreted by a trained physician, they may assist in diagnosis during either neurovascular or cardiovascular interventionsa procedures. The iMRX system is designed such that the imaging sub-systems cannot operate simultaneously and only in accordance with their respective cleared intended use.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·January 8, 2020

    Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·October 6, 2021

    Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·October 6, 2021

    Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·October 6, 2021

    Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·April 20, 2022