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510(k) Data Aggregation

    K Number
    K181789
    Device Name
    VeriSuite
    Manufacturer
    MedCom GmbH
    Date Cleared
    2018-09-21

    (78 days)

    Product Code
    LHN, IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MedCom GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VeriSuite is an image processing software for verification of the patient position of a correction vector for the treatment of tumors during a radiation therapy with photons, electrons (from a linear accelerator) or particles (protons). An authorized person must evaluate the correctness of the calculation and approve the result for further usage. The system shall only be used after correct installation in appropriate treatment rooms by trained personnel. Legal regulations especially regulation for the operation of X-ray devices must be regarded. VeriSuite must not be used for diagnostic purposes.
    Device Description
    VeriSuite® is an image processing system for verification and correction of the patient position during a radiation therapy treatment. The verification or correction is performed by a comparison of the current patient treatment position with a CT series of the patient and information from the radiation therapy planning. The correction can also be based on fiducial, radio-opaque markers that are implanted in the patient. With the fluoroscopy extension it is possible to observe the position of the patient and the treatment area during the treatment. Mainly the movements of the patient caused by breathing are in the focus. This information can be used to interrupt the treatment by the user. With the 3D3D extension it is possible to compare two CT volumes with each other. The positioning volume is received from the TRCS (i.e. from a second CT device located in the treatment room.) VeriSuite® is a system of devices consisting of the VeriSuite® software and a number of hardware devices.
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    K Number
    K180308
    Device Name
    Prelude
    Manufacturer
    MedCom GmbH
    Date Cleared
    2018-03-27

    (53 days)

    Product Code
    MUJ, LHO
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MedCom GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prelude Planning Software for the electron beam IORT treatment can be used for any malignant and benign tumor. For Prelude no limitation is given to the patient population. Local/Regional recommendations or guidelines may indicate patient who will benefit from IORT more than from other treatment modalities. In general, since Prelude is tailored for the planning with the Mobetron®, it can be used for IORT treatment planning, if a patient is prescribed to be treated with the Mobetron®.
    Device Description
    The Prelude software supports the IORT treatment workflow. Prelude Dosimetric measurement data of the radiation device can be displayed by selecting the machine parameters. Upon that information the user can easily plan the treatment and the software calculate the required parameters for the IORT devices. For quality assurance the machines parameters can be recorded and visualized. For the calculation of the output factors or the monitor units either the IAEA or AAPM protocol is followed. The software is intended to be used by medical professionals in the area of radiation therapy. The main purpose is to plan the technical parameters required to perform an electron beam IORT to treat both malignant and benign tumors
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    K Number
    K170841
    Device Name
    BiopSee, Mobile US
    Manufacturer
    MedCom GmbH
    Date Cleared
    2017-07-26

    (127 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MedCom GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BiopSee bundled system is a combination of MobileUS providing the "Medical Image Processing Workstation" which acquires and displays ultrasound images from external ultrasound scanners and the BiopSee "Image Fusion Navigation Software" which is a stereotaxic accessory for Ultrasound (US) devices. The BiopSee system is intended to be used in clinical interventions and for anatomical structures in a clinical setting where US imaging is currently used for visualizing such procedures. It displays the simulated insertion tool such as a biopsy needle on a computer monitor that shows images of the target organs and the projected future path of the interventional instrument. The patient population is mainly people who need prostate biopsy. It is intended to be used mainly in the Urological departments for prostate biopsies. The BiopSee system is not intended to be used as a standalone diagnostic image device, since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always be seen as an additional source of information. The BiopSee system when connected with an electromagnetic tracker should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment. BiopSee is a prescription device.
    Device Description
    The BiopSee bundled system (also called BiopSee System) is a medical image processing workstation that provides image quided instrument navigation. The hardware part (MobileUS) consists of the system unit which includes a CPU, a monitor, medical-grade keyboard, mouse and power supply and a medical trolley. It is designed to display ultrasound images from different sources. Optionally it can be equipped with an electromagnetic positioning system to track the ultrasound probe or other medical instruments. The system is able to load different image modalities such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Positron emission tomography (PET) and allows organ delineation and planning instrument access paths within the 3D dataset. It is designed to display 2D images from commercially available ultrasound systems and either reconstruct a 3D ultrasound image or fuse the images with pre-loaded other datasets. The BiopSee software can be installed on standard PCs under Microsoft Windows operating systems which follow the minimum requirements described in the service manual, similar to MobileUS hardware. BiopSee is designed to work in combination with an ultrasound scanner (the Ultrasound System is used in order to display the live US images) and a probe, a positioning system (to track the position of the probe) and medical navigation instruments (to track the position of the medical instruments like needles). The ultrasound scanners connected must be tested with the BiopSee System and shall be legally marketed in the US.
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    K Number
    K163119
    Device Name
    NaviSuite SSI Edition
    Manufacturer
    MEDCOM GMBH
    Date Cleared
    2017-05-01

    (174 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCOM GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NaviSuite SSI Edition is used to support a clinical ultra-sound session and follow percutaneous procedure by means of providing additional real-time image information from a 2nd modality like CT or MR or US or its combination with the possibility to plan the ideal treatment procedure. The second modality or their combinations are acquired and 3D is generated inside the software permitting the anatomical correlation with the patient position. "The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information." "The 2nd modality image only should not be used for diagnostic purposes."
    Device Description
    NaviSuite SSI Edition 0.9.10 is a medical product to support a clinical ultrasound session and follow percutaneous procedure by means of providing additional realtime image information from a 2nd modality like CT or MR or US or its combination with the possibility to plan the ideal treatment procedure. The second modality or their combinations are acquired and a 3D is generated inside the software permitting the anatomical correlation with the patient position. By using the 2nd modality image the user gains security in assessing the morphology of the ultrasound image and obtains a virtual feed-back on the procedure provided by the virtual percutaneous tool position enabled by a dedicated receiver, its treatment region delineated by custom tables and a dedicated computation in 3D of the target region. The 2nd modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient probably not congruent with the current (real) patient situation and shall therefore always been seen as an additional source of information. NaviSuite SSI Edition is a software designed for use together with an ultrasound device: AIXPLORER (K142100).
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    K Number
    K133914
    Device Name
    VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE
    Manufacturer
    MEDCOM GMBH
    Date Cleared
    2014-04-03

    (101 days)

    Product Code
    LHN, CLA, IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCOM GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VeriSuite patient position verification and correction of the patient's position during a radiotherapy treatment with external beams or charged particles. It is based on stereoscopic X-ray images and DRRs calculated from a CT image series of the treatment region of the patient and information from the treatment planning.
    Device Description
    VeriSuite is an image processing system for verification and correction of the patient position during a radiation therapy treatment. The verification or correction is performed by a comparison of X-ray images that are acquired during the treatment with DRRs (digital reconstructed radiographs) calculated from a CT image series of the patient and information from the radiation therapy planning. The correction can also be based on fiducial, radio-opaque markers that are implanted in the patient. With the fluoroscopy extension it is possible to observe the position of the patient and the treatment area during the treatment. Mainly the movements of the patient caused by breathing are in the focus. This information can be used to interrupt the treatment by the user. VeriSuite is a system of devices consisting of the VeriSuite software and a number of hardware devices.
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    K Number
    K102237
    Device Name
    PVS MODEL 1.0
    Manufacturer
    MEDCOM GMBH
    Date Cleared
    2010-11-23

    (106 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCOM GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PVS patient position verification system is used for verification and correction of the patient's position during a radiotherapy treatment with external beams or charged particles. It is based on stereoscopic X-ray images and DRRs calculated from a CT image series of the treatment region of the patient and information from the treatment planning.
    Device Description
    Not Found
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    K Number
    K100056
    Device Name
    MEDCOM RT-VIEWER SYSTEM
    Manufacturer
    MEDCOM GMBH
    Date Cleared
    2010-05-07

    (119 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCOM GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bridge-RT is a Medical Device intended to be used for reviewing and assessment of DICOM based datasets which may occur in a radiotherapy environment. It is used by qualified specialist to load and display data generated by different DICOM devices including: RT-STRUCT, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR and PET. The software provides the radiotherapy specialist with the necessary visualization and image manipulation tools to review, present or compare DICOM-RT related datasets including the geometrical super imposition of 3D plan data. Bridge-RT is intended for reviewing purposes only and is not capable to generate new or modified RT plan data.
    Device Description
    Not Found
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    K Number
    K092653
    Device Name
    VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8
    Manufacturer
    MEDCOM GMBH
    Date Cleared
    2009-09-18

    (21 days)

    Product Code
    LHN, 510, IZO, MAN, VER
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCOM GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VeriSuite patient position system is used for verification and correction of the patient's position during a radiotherapy treatment with external beams or charged particles. It is based on stereoscopic X-ray images and DRRs calculated from a CT image series of the treatment region of the patient and information from the treatment planning.
    Device Description
    VeriSuite is an image processing system for verification and correction of the patient position during a radiation therapy treatment. The verification or correction is performed by a comparison of X-ray images that are acquired during the treatment with DRRs (digital reconstructed radiographs) calculated from a CT image series of the patient and information from the radiation therapy planning, The correction can also be based on fiducial, radio-opaque markers that are implanted in the patient. VeriSuite is a system of devices consisting of the VeriSuite software and a number of hardware devices: - Beam limiting collimator device (Ralco 302) - X-ray generator (Sedecal XHF 835) - - X-ray tubes (Varian A277 or A272) - Flat panel digital imager (Varian 4030E - Optional: All these hardware devices are legally marketed in the US as listed in previous section D.
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    K Number
    K080742
    Device Name
    VERISUITE 1.6, VERISUITE-PARTICLE 1.6
    Manufacturer
    MEDCOM GMBH
    Date Cleared
    2008-05-09

    (53 days)

    Product Code
    IYE, 510, EXA, IZO, MQB, VER
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCOM GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VeriSuite patient position verification system is used for verification and correction of the patient's position during a radiotherapy treatment with external beams or charged particles. It is based on stereoscopic X-ray images and DRRs calculated from a CT image series of the treatment region of the patient and information from the treatment planning.
    Device Description
    Not Found
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    K Number
    K032550
    Device Name
    EXOMIO, MODEL 2.0 SP1
    Manufacturer
    MEDCOM GMBH
    Date Cleared
    2003-09-25

    (38 days)

    Product Code
    KPQ, EXO
    Regulation Number
    892.5840
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCOM GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Exomio Radiation Treatment Simulation System is used for CT-based diagnostic image analysis, while also providing treatment planning tools to the physician, such as: contouring and segmentation (manual or automatic), radiation treatment field editing and 3D visualization of the virtual treatment setup. Moreover, it includes useful treatment setup export capabilities to enable the communication with compatible medical devices.
    Device Description
    Exomio is a programmable (Software) medical device aiming to fully provide the physicians with necessary visualisation and image manipulation tools to prepare the patient's RT simulation virtually in absence of the physical patient and the physical simulator. This is done using the patient's CT data set, including the attached on the patient's skin reqistration markers, instead of the physical patient. This process it called virtual simulation and Exomio, as well as other similar systems, is called CT-based or Virtual Radiation Treatment Simulation System. Exomio provides tools to support clinician's decision making through the use of enhanced visualization of the patient data set and treatment parameters. 3-D visualization provides an excellent overview of the patient's anatomy. In addition, the relation between treatment beams and tumor can be investigated in detail using Exomio's navigation tools. All this unique functionality is provided to the clinics with aim the overall improvement of the RT simulation process. Exomio is able, using the DICOM standard, to export all parameters necessary for the treatment of the patient as well as the images to other devices supporting DICOM RT Plan and Structure Set. This way the whole procedure becomes a lot faster savinq even more time for the physician and the rest medical staff.
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