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510(k) Data Aggregation

    K Number
    K060870
    Device Name
    AVANZA
    Manufacturer
    MDS NORDION
    Date Cleared
    2006-05-15

    (46 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Applicant Name (Manufacturer) :

    MDS NORDION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Avanza patient positioning table is used as a universal patient support to accurately and reproducibly position patients for radiation therapy and simulation. The Avanza is used with THERATRON® Equinox™ units and is also adaptable to third party radiation therapy treatment devices.
    Device Description
    The Avanza Patient Positioning Table is a powered radiation therapy patient support assembly that is substantially equivalent in functionality and performance as the previously cleared Precise Treatment Table. The Avanza Patient Positioning Table is supported by a mechanism and features several functions including isocentric rotation, column rotation, longitudinal, lateral, and vertical motions. The computer-controlled table can be activated by using the table mounted control panels or by using an optional hand control.
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    K Number
    K053485
    Device Name
    THERATRON EQUINOX, MODELS 80 CM AND 100 CM
    Manufacturer
    MDS NORDION INC.
    Date Cleared
    2006-03-09

    (84 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    MDS NORDION INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic.
    Device Description
    The Theratron Equinox consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beam-stopper style counterweight. The design of this device is similar to predicate device Theratron Elite 80 and 100.
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    K Number
    K051065
    Device Name
    RAYCELL X-RAY BLOOD IRRADIATOR
    Manufacturer
    MDS NORDION
    Date Cleared
    2005-05-26

    (30 days)

    Product Code
    MOT
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MDS NORDION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Raycell" X-ray Blood Irradiator is intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease (GVHD) in accordance with applicable FDA, AABB, Health Canada, and European guidelines. The Raycell" X-ray Blood Irradiator is also intended for use in the irradiation of intra-operative (between three) blood for cancer patients undergoing surgery to assist in the prevention of metastasis.
    Device Description
    Not Found
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    K Number
    K050963
    Device Name
    GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN
    Manufacturer
    MDS NORDION
    Date Cleared
    2005-05-20

    (32 days)

    Product Code
    MOT
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MDS NORDION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To irradiate cellular blood products to inactivate T-lymphocytes in order to prevent graft versus host disease.
    Device Description
    The basic operation of an irradiator involves placing of the blood product into the beaker, loading the beaker into the gammacell, closing the safety door and pressing the 'start' button. Upon start of the cycle, the unit moved the beaker to the irradiation position. Concurrently, the timer begins to count down (irradiation time is pre-programmed by the site supervisor) from the set time and when the time reaches zero, the sample returns to the unload position and the audible alarm sounds.
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    K Number
    K032684
    Device Name
    RAYCELL
    Manufacturer
    MDS NORDION
    Date Cleared
    2003-09-26

    (28 days)

    Product Code
    MOT
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MDS NORDION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Raycell™ Shielded Cabinet X-ray System is intended for the irradiation of blood and blood products packaged in transfusion bags when irradiation to reduce the risk of Graft versus Host Disease is indicated, and is used in accordance with "Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products" (22 July 1993 memorandum from Acting Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA to all registered blood establishments).
    Device Description
    The Raycell Shielded Cabinet X-ray System consists of a sample holder (canister) between the two (2) x-ray tubes, dual power supplies, radiation shielding, control electronics, cooling assemblies and operator controls. The radiation source of the Raycell™ Shielded Cabinet X-ray System includes of two vertically opposed xray tubes contained in a shielded enclosure. It is identical to the predicate device with the exception of labeling changes to reflect the new product name and identify MDS Nordion as the manufacturer.
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    K Number
    K020971
    Device Name
    DCM 2.0
    Manufacturer
    MDS NORDION AB
    Date Cleared
    2002-06-06

    (72 days)

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

    MDS NORDION AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DCM is a three-dimensional radiotherapy dose engine for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. Based on quality assured radiation therapy input data Dose Calculation Module is used to plan radiation treatment with: - Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 6 . to 25 MeV - Cobalt-60 units . DCM will calculate dose for 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorized and dynamic wedges; customized blocking and bolus.
    Device Description
    DCM 2.0 is intended for calculations of dose plans, the calculations are based on DICOM objects and other information conveyed by a control communication protocol from the THERAPLAN treatment planning system. DCM is a three-dimensional radiotherapy dose engine for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. Based on quality assured radiation therapy input data Dose Calculation Module (DCM) is used to plan radiation treatment with: - Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 6 . to 25 MeV - . Cobalt-60 units DCM will calculate dose for 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorized and dynamic wedges; customized blocking and bolus.
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    K Number
    K010682
    Device Name
    HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM
    Manufacturer
    MDS NORDION
    Date Cleared
    2001-06-05

    (90 days)

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

    MDS NORDION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Helax-TMS is a 3D radiotherapy treatment planning system for radiation dose planning, but not treatment, of patients undergoing external beam or brachytherapy treatment in the oncology clinic. The system is designed to lead the user through a logical flow planning process. Based on quality assured radiation therapy input data Helax-TMS is used to plan radiation treatments with: - Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 4 to 50 MeV, proton energies from 1 to 275 MeV as well as cobalt-60 units. Helax-TMS will plan 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorised and dynamic wedges; customised blocking; compensating filters; and bolus. - Brachytherapy units for patients undergoing interstitial or intracavitary treatment in the oncology clinic. Export capabilities exists as part of Helax-TMS to verify beam and patient data, dose planning results, and provide on-line information to block-cutting devices and milling machines, multi-leaf collimator control units, as well as record and verify systems.
    Device Description
    Helax TMS is a 3D Radiotherapy Treatment Planning (RTP) system for radiation dose planning of patients undergoing external beam and brachytherapy treatment in the Oncology clinic. Helax-TMS is a 3-D system, using modern algorithms for dose calculations. The user has the option of selecting either a convolution/superposition pencil beam or a Collapsed Cone algorithm for photons, a Gaussian pencil beam model for electrons, and a proton dose calculation. A brachytherapy module is integrated into Helax-TMS for treatment modeling of interstitial and intracavity brachytherapy techniques. The system software is designed to lead the user through a logical flow planning process.
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    K Number
    K011246
    Device Name
    DCM 1.0
    Manufacturer
    MDS NORDION
    Date Cleared
    2001-05-23

    (30 days)

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

    MDS NORDION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001006
    Device Name
    THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE
    Manufacturer
    MDS NORDION
    Date Cleared
    2000-04-27

    (29 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    MDS NORDION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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