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510(k) Data Aggregation

    K Number
    K123357
    Device Name
    ONQ RTS
    Date Cleared
    2012-12-28

    (58 days)

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

    ONCOLOGY SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OnQ rts software is stand-alone software that provides a means of visualizing and comparing medical image data from multiple DICOM compliant imaging modality devices. It is used for the display, evaluation, co-registration and fusion of medical images, contour of anatomical structures and radiation therapy dose distributions to aid in radiation therapy planning, diagnostic radiology, oncology and other medical specialties. Note: The software is not for use with digital mammography
    Device Description
    OnQ rts® is a stand-alone medical imaging software program that imports DICOM images from different modalities and provides imaging tools to visualise, compare, contour, co-register medical images, anatomical structures and radiation therapy dose distributions. These procedures are performed by manual, semi-automatic techniques which extract anatomical information for image contouring and analysis from the DICOM data. The system can operate as a single workstation or with multiple workstations, with one of them being the server networked with multiple clients and remotely via Citrix® terminal services. OnQrts is not intended for use with hand-held mobile devices. OnQ rts software includes the import and export of DICOM data securely via a network connection. The imported images, from different modalities, are processed to provide a clinical picture of the anatomy and corresponding radiation therapy doses. OnQrts co-registers images together, using rigid image registration (RIR) and elastic/deformable image registration (DIR) or a combination of both. These images can display imported or generated contours (anatomical and dose) overlaid onto the fused images. OnQ rts contouring can be performed manually or .automatically from a library of user defined or prepared pre-contoured CT cases. The library atlas files act as a template that is then mapped to the patients' anatomy. The contours are reviewed and approved before export, e.g. to radiotherapy planning software. OnQrts can import radiation therapy treatment planning data (dose and dose distributions) which can then be displayed for review, radiation therapy dose comparison and analysis. The software provides contour companson tools using a range of comparison metrics that highlight variations between VOIs in terms of size, shape and location. OnQ rts is not a radiation therapy treatment planning system and can only display and evaluate dose plan information generated from radiation therapy equipment.
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    K Number
    K092522
    Device Name
    ACU007S
    Date Cleared
    2009-11-20

    (94 days)

    Product Code
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    ONCOLOGY SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Oncology Systems Model ACU-007S Source Assembly, with an individual activity up to 12Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, head and neck, bile duct brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with other interventions, such as external beam radiation therapy, or chemotherapy.
    Device Description
    Oncology Systems, Inc. Model ACU-007S is a singly-encapsulated 192Iridium Brachytherapy Source. It consists of a single solid radioactive 192 Iridium pellet sealed in a stainless steel capsule that is attached to a cable. Its purpose is to permit manipulation by the Oncology Systems, Inc AccuSource 1000 remote afterloader system for the treatment of cancer and other lesions.
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    K Number
    K051753
    Device Name
    ACCU-SOURCE
    Date Cleared
    2006-03-29

    (273 days)

    Product Code
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    ONCOLOGY SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Accu-Source™ remote control high dose rate afterloading brachytherapy system is intended for the treatment of cancer and other lesions by intracavitary, interstitial, intralumenal, intraoperative, endobronchial and surface applicator irradiation treatments.
    Device Description
    The Accu-Source™ is a remote afterloading system for High Dose Rate Brachytherapy. The system is designed to deliver a predetermined dose of radiation to organs and tissue via a radioactive source. The ACCU-SOURCE™ system includes an operator console and a remote afterloading device. The ACCU-SOURCE™ system has a tungsten shielded storage safe which houses a radioactive source when the system is not in use. There are encoders and motors used in conjunction with electronic circuitry that drive the source and keep track of its position. A battery is used for back-up power and an uninterruptible power supply is also integrated into the ACCU-SOURCE™ system to charge the battery backup subsystem.
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    K Number
    K973540
    Device Name
    ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS
    Date Cleared
    1997-12-17

    (90 days)

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

    ELEKTA ONCOLOGY SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EOS iCom/QuickMode Software Options, as with the predicate SLi Series system, is intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
    Device Description
    The EOS iCom/QuickMode Software Options are improvements to the existing SLi Series Linear Accelerators which have previously been cleared for commercial distribution.
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