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510(k) Data Aggregation

    K Number
    K151233
    Device Name
    Monaco
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Date Cleared
    2015-07-07

    (60 days)

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

    IMPAC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Monaco system is used to make treatment plans with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: - contouring - image manipulation - simulation - image fusion - plan optimization - QA and plan review
    Device Description
    Monaco is a radiation treatment planning system that first received FDA clearance in 2007 (K071938). The modified system received clearance in 2009, when Volumetric Modulated Arc Therapy (VMAT) planning capability was added (K091179), when Dynamic Conformal Arc planning was added (K110730), and most recently when the system's intended use was expanded to include electron treatment planning, among other changes (K132971). The Monaco system accepts patient diagnostic imaging data and "source" dosimetry data from a linear accelerator. The system then permits the user to display and define (contour) the target volume to be treated and critical structures which must not receive above a certain level of radiation on these diagnostic images. Based on the prescribed dose, the user, a Dosimetrist or Medical Physicist, can create multiple treatment scenarios involving the number, position(s) and energy of radiation beams and the use of beam modifiers between the source of radiation and the patient to shape the beam. The Monaco system then produces a display of radiation dose distribution within the patient, indicating doses to the target volume and surrounding structures. The "best" plan satisfying the prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes. The Monaco system supports 3D conformal planning, IMRT, and Dynamic Conformal. It supports inverse and forward planning workflows.
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    K Number
    K141572
    Device Name
    MOSAIQ ONCOLOGY INFORMATION SYSTEM
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Date Cleared
    2014-09-05

    (85 days)

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

    IMPAC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MOSAIO® is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. It lets users: - . Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications. - Generate and keep medication formulary lists and calculate applicable medication . dosages for medical oncology. - Import, view, annotate, adjust, enhance, manage and archive images. - Compare radiation treatment plans and evaluate dose coverage. - Design leaf plans for operation with radiotherapy treatment machines that have multileaf ● collimators. - Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIO® reads actual settings from the treatment machine through the machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user. - . View reference images to setup treatment. MOSAIQ® refers to predefined settings to help treatment machine setup, and communicates patient and machine setup instructions. - Record actual delivered radiation values in an electronic chart to track treatment. ● - Use stereotactic localization to calculate set-up coordinates for treatments. . MOSAIQ® is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.
    Device Description
    MOSAIQ is a multi-functional, integrated software suite that forms a comprehensive electronic oncology management system for medical and radiation oncology facilities. For both medical and radiation oncology users, MOSAIQ provides image-enabled electronic patient charting and record management as well as medical transcription and billing functionality. For radiation oncology users, it also includes the ability to import and export radiation treatment plan information, stereotactic localization, treatment plan review, the ability to plan multileaf collimator (MLC) shapes, and verify and record treatment setup and delivery. This Premarket Notification addresses the addition of the Locate module for Radiation Oncology, which adds stereotactic localization capability to MOSAIQ.
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    K Number
    K132971
    Device Name
    MONACO
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Date Cleared
    2013-11-20

    (58 days)

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

    IMPAC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy. two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: - contouring - image manipulation - simulation - image fusion - plan optimization - QA and plan review
    Device Description
    Monaco is a radiation treatment planning system that first received FDA clearance in 2007 (K071938). The modified system received clearance in 2009, when Volumetric Modulated Arc Therapy (VMAT) planning capability was added (K091179) and again when Dynamic Conformal Arc planning was added (K110730). The Monaco system accepts patient diagnostic imaging data and "source" dosimetry data from a linear accelerator. The system then permits the user to display and define (contour) the target volume to be treated and critical structures which must not receive above a certain level of radiation on these diagnostic images. Based on the prescribed dose, the user, a Dosimetrist or Medical Physicist, can create multiple treatment scenarios involving the number, position(s) and energy of radiation beams and the use of beam modifiers between the source of radiation and the patient to shape the beam. The Monaco system then produces a display of radiation dose distribution within the patient, indicating doses to the target volume and surrounding structures. The "best" plan satisfying the prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.
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    K Number
    K123230
    Device Name
    MOSAIQ ONCOLOGY INFORMATION SYSTEM
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Date Cleared
    2012-12-12

    (58 days)

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

    IMPAC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MOSAIQ® is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. It lets users: - · Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications. - Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology. - Import, view, annotate, adjust, enhance, manage and archive images. - Compare radiation treatment plans and evaluate dose coverage. - Design leaf plans for operation with radiotherapy treatment machines that have multileaf . collimators. - . Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIQ® reads actual settings from the treatment machine through the machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user. - View reference images to setup treatment. MOSAIQ® refers to predefined settings to . help treatment machine setup, and communicates patient and machine setup instructions. - Record actual delivered radiation values in an electronic chart to track treatment. . MOSAIQ® is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.
    Device Description
    MOSAIQ is a multi-functional, integrated software suite that forms a comprehensive electronic oncology management system for medical and radiation oncology facilities. For both medical and radiation oncology users, MOSAIQ provides image-enabled electronic patient charting and record management as well as medical transcription and billing functionality. For radiation oncology users, it also includes the ability to import and export radiation treatment plan information, the ability to plan multileaf collimator (MLC) shapes, and verify and record treatment setup and delivery. This Premarket Notification addresses the addition of the "Evaluate" module, which calculates and displays dose volume histograms (DVHs) for the purpose of review and evaluation of radiation treatment plans.
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    K Number
    K120067
    Device Name
    MOSAIQ ONCOLOGY INFORMATION SYSTEM
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Date Cleared
    2012-02-28

    (50 days)

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

    IMPAC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users: - Supply electronic patient charts and assemble care plans, order diagnostic . tests, and prescribe medications. - Import, view, annotate, manipulate, enhance, and archive images. . - Import, keep, and export information related to patient treatments to ● monitor treatment progress from a central location. This includes orders, documents, lab information, and other related information from compatible programs. - Generate and keep medication and formulary lists and calculate applicable . medication dosages for medical oncology. - Design leaf plans for operation with radiotherapy treatment machines that . have multileaf collimators. Users can give, view and change geometric data related to treatment fields, including the MLC accessory. - Ensure plans imported from treatment planning systems agree with . treatment machine constraints. Additionally, MOSAIQ: - . Supplies other administrative functionality necessary to operate medical and radiation oncology departments. - . Shows reference images for setup purposes, refers to predefined settings to help treatment machine setup, and tells clinicians of necessary steps before treatment. - Reads actual settings from the treatment machine through the machine's ● communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system inhibits treatment. - . Verifies the actual treatment against radiation treatment plans. At applicable points during the treatment, it records the actual delivered values to provide treatment tracking. MOSAIQ supports information flow among healthcare facility personnel. It can be used wherever radiotherapy and/or chemotherapy are prescribed. MOSAIQ is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.
    Device Description
    MOSAIQ is a multi-functional, integrated software suite that forms a comprehensive electronic oncology management system for medical and radiation oncology facilities. For both medical and radiation oncology users. MOSAIQ provides image-enabled electronic patient charting and record management as well as medical transcription and billing functionality. For radiation oncology users, it also includes the ability to import and export radiation treatment plan information, the ability to plan multileaf collimator (MLC) shapes, and verify and record treatment setup and delivery. Previously, three of the components within MOSAIQ were cleared through the 510(k) process individually. The ViewStation software (K011694) provides the ability to to import, view, annotate, manipulate, enhance, manage and archive medical images and includes patient positioning functionality. The MLC Fit software (K991133) allows users to define MLC leaf shapes for radiation treatment plans. The SEQUENCER software (K981313) connects to the treatment unit (e.g. linear accelerator) and compares its setup to the predefined treatment field in the treatment chart. SEOUENCER inhibits treatment if errors are detected, records actual treatment unit parameters, and allows this information to be stored and/or printed as part of the treatment record. MOSAIQ includes the ViewStation, MLC Fit and SEQUENCER software applications as well as other applications that were not classified as medical devices when considered as individual products.
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    K Number
    K043412
    Device Name
    MODIFICATION TO: VIEWSTATION
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Date Cleared
    2004-12-20

    (10 days)

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

    IMPAC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ViewStation supports image and information flow among health care facility personnel. ViewStation can be used whenever digital images and associated data are the means for communicating information. ViewStation is not intended for use in diagnosis. The intended use of ViewStation is to provide health care facility personnel with an effective means to utilize patient images during the course of therapy or treatment. ViewStation allows users to import, view, annotate, manipulate, enhance, manage, and archive patient images and associated information are stored in a database, providing users access to the information necessary to perform their functions.
    Device Description
    The primary function of ViewStation is to provide a means to more effectively manage image information in a therapy or treatment environment. ViewStation provides the ability to import, view, annotate, manipulate, enhance, and archive patient images during the course of therapy, treatment, and follow-up. ViewStation imports existing digital images acquired or generated by other products. ViewStation retains the original image, which was acquired or generated by a third party product. With these facts in mind, the goal of ViewStation is to make electronic patient image information more accessible throughout the department. IMPAC is providing a tool to increase department productivity since digital images, unlike films, do not have to be physically transferred from one station to another.
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    K Number
    K013531
    Device Name
    QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Date Cleared
    2001-11-07

    (15 days)

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

    IMPAC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QwikSIM Virtual Simulation System may be used by radiation oncologists, medical physicists, and medical dosimetrists for patient localization, image import and review, tumor and normal tissue delineation, and virtual simulation of treatment unit setup during the treatment planning process of external beam radiotherapy treatment. This information may then be exported to a treatment planning system for dose calculation.
    Device Description
    The QwikSIM Virtual Simulation System provides fast and accurate visualization, contouring and beam definition to streamline the radiation therapy planning process. QwikSIM imports image data, and provides an array of tools to straining and adjusting images. Manual and automatic contouring tools allow for anatomical and tumor contour definition. Beam placement and visualization tools facilitate treatment port definition, isocenter placement and laser center placement. The resulting plan data can then be used with laser positioning systems for patient marking and exported to therapy planning systems for dose calculation.
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    K Number
    K011694
    Device Name
    VIEWSTATION
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Date Cleared
    2001-08-29

    (90 days)

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

    IMPAC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ViewStation supports image and information flow among health care facility personnel. ViewStation can be used whenever digital images and associated data are the means for communicating information. ViewStation is not intended for use in diagnosis. The images and associated information are stored in a database, providing users access to the information necessary to perform their functions. The intended use of ViewStation is to provide health care facility personnel with an efficient and effective means to utilize patient images during the course of therapy or treatment. ViewStation allows users to import, view, annotate, manipulate, enhance, manage, and archive patient images.
    Device Description
    The primary function of ViewStation is to provide a means to move image information in a therapy or treatment environment. ViewStation provides the ability to import, view, annotate, manage, and archive patient images during the course of therapy, treatment, and follow-up. ViewStation imports existing digital images acquired or generated by other products. ViewStation retains the original image, which was acquired or generated by a third party product.
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    K Number
    K991133
    Device Name
    MLC FIT
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Date Cleared
    2000-03-27

    (360 days)

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

    IMPAC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MLC Fit is to be used to define leaf plans for use with radiation treatment machines equipped with multileaf collimators manufactured by Siemens Medical Systems, Varian Associates, and With manned conniness Inc. This method of defining the geometric parameters associated with treatment fields can be used whenever a conformal treatment field is desired.
    Device Description
    The primary function of MLC Fit is to provide a means to define multileaf collimator leaf plans based on a user defined shape of a desired treatment area for use with a cancer radiotherapy treatment machines equipped with multileaf collimators manufactured by Siemens Medical Systems, Varian Associates, or Elekta Oncology Systems, Inc. Users may create, view, and edit MLC leaf data as well as other geometric parameters associated with treatment field definitions.
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    K Number
    K981313
    Device Name
    SEQUENCER
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-07-09

    (90 days)

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

    IMPAC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SEQUENCER is to be used to facilitate the delivery of defined radiotherapy treatment plans. SEQUENCER verifies the settings on a radiotherapy treatment machine prior to treatment and records the actual parameters after treatment. SEQUENCER can be used whenever radiotherapy treatment is prescribed.
    Device Description
    The primary function of SEQUENCER is to assist in setting up the patient for treatment and verifying that the treatment setup is correct for a patient undergoing radiation therapy. SEQUENCER may be used to help in the setup of geometric and console parameters and verify the set parameters on the treatment machine with the planned values. After treatment the actual values can be recorded. This assists in tracking the dose given to the specified location.
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