BEUDAMED
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    ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49973B ET DATA PREP / REVIEW SYSTEM 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·May 7, 2014

    ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·June 11, 2014

    ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·August 13, 2014

    The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument)

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·March 4, 2015

    BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·February 19, 2014

    Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·August 20, 2014

    Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·April 23, 2014

    BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·November 25, 2015

    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 20, 2016

    Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. They are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field. Radiology.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·September 30, 2015

    Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.

    FDA Enforcement
    Class I ·Terminated·Brainlab AG·January 27, 2016

    ExacTrac Vero is a Patient Positioning System for Radiation therapy.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·June 15, 2016

    ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·April 1, 2015

    BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·September 4, 2013

    AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·February 14, 2018

    Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 17, 2018

    Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·August 6, 2014

    ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·March 21, 2018

    iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 21, 2015

    Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 18, 2017