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510(k) Data Aggregation

    K Number
    K132236
    Device Name
    .DECIMAL PROTON APERTURE
    Manufacturer
    .DECIMAL, INC.
    Date Cleared
    2013-10-16

    (90 days)

    Product Code
    IXI
    Regulation Number
    892.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    .DECIMAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    .decimal's Aperture manufacturing service manufactures the ring and solid core apertures for intensity modulation of external beam proton radiation therapy. The apertures are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
    Device Description
    The .decimal Proton Aperture is a Brass Core encased in a reusable steel ring (or material with similar attenuating properties) with a 2D hole cut from it, which defines the area that is to be treated with a proton beam. The design for a .decimal Proton Aperture is generated out of a customer's treatment planning system (TPS) or physician's specifications and is unique to each patient. The device functions as a beam shaping block. The apertures are inserted into the gantry's snout to shape and focus the beam as it exits the gantry en route to the targeted area. As radiation is passed through the gantry, the beam passes through aperture and it will be blocked. The opening of the aperture where there is no brass, the radiation will pass through targeted area defined by the radiation therapy professional.
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    K Number
    K123015
    Device Name
    .DECIMAL PHOTON BLOCK
    Manufacturer
    .DECIMAL, INC.
    Date Cleared
    2012-11-21

    (54 days)

    Product Code
    IXI
    Regulation Number
    892.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    .DECIMAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    .decimal's Photon Block manufacturing service manufactures Photon Blocks for external beam photon radiation therapy. The Photon Block is designed by the customer's treatment planning system or physician specifications to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area. Photon Blocks are intended for use by healthcare professionals. In IMRT therapy for cancer, a photon beam is aimed at the cancerous tissue using a linear accelerator. The linear accelerator is rotated around the patient while the patient lies on a treatment table; the linear accelerator consists of the gantry, which rotates around the patient. The gantry contains a collimator, which points at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires custom-made, beam modifying, patient specific devices called: Photon Block. The Photon Block is inserted into the gantry's collimator to shape and focus the beam as it exits the gantry en route to the targeted area. The photon block is also called a cerrobend block, which defines the area that is to be treated with the photon beam. Photon Blocks are generated out of the treatment planning system or physician's specifications and are unique to each patient and each gantry angle.
    Device Description
    The .decimal Photon Block is a Cerrobend block (or material with similar attenuating properties) with a 2D pattern/hole made from it, which defines the area that is to be treated with a photon beam. The design for a .decimal Photon Block is generated out of a customer's treatment planning system (TPS) or physician's specifications and is unique to each patient. The device functions as a beam shaping block. The block fits into a customer's linear accelerator. As radiation is passed through the collimator, the beam passes through cerrobend and it will be blocked the opening of the photon block where there is no ccrrobend, the radiation will pass through targeted area defined by the radiation therapy professional.
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    K Number
    K111759
    Device Name
    .DECIMAL ELECTRON APERTURE
    Manufacturer
    .DECIMAL, INC.
    Date Cleared
    2011-09-09

    (79 days)

    Product Code
    IXI
    Regulation Number
    892.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    .DECIMAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K091911
    Device Name
    BOLUS COMPENSATOR
    Manufacturer
    .DECIMAL, INC.
    Date Cleared
    2009-07-21

    (26 days)

    Product Code
    IXI
    Regulation Number
    892.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    .DECIMAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bolus Compensators are used by radiation therapy professionals for the treatment of cancer patients. They are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. Each Bolus Compensator must be validated and approved by the radiation therapy professional prior to use on a patient.
    Device Description
    .decimal's Bolus Compensator manufacturing service manufactures the solid Bolus Compensators for intensity modulation of external beam radiation therapy. The Bolus Compensators are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
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    K Number
    K083672
    Device Name
    P.D SOFTWARE
    Manufacturer
    .DECIMAL, INC.
    Date Cleared
    2009-04-13

    (123 days)

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

    .DECIMAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The p.d software is used by radiation therapy professionals to assist in the treatment of cancer patients. The p.d software takes a Treatment Planning System design of a compensating filter which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface. And the software converts Treatment Planning System compensator filter file into a .decimal file format. Optionally the user may elect to design a beam shaping compensator filter based on Treatment Planning System's data which will be transferred back into the Treatment Planning System for final dose verification. The customer uses the software in-house before sending the file to .decimal to be manufactured. Each filter must be QA'd and approved by a radiation therapy professional prior to use on a patient.
    Device Description
    The p.d software is used by radiation therapy professionals to assist in the treatment of cancer patients. The p.d software takes a Treatment Planning System design of a compensating filter which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface. And the software converts Treatment Planning System compensator filter file into a .decimal file format. Optionally the user may elect to design a beam shaping compensator filter based on Treatment Planning System's data which will be transferred back into the Treatment Planning System for final dose verification. The customer uses the software in-house before sending the file to .decimal to be manufactured. Each filter must be QA'd and approved by a radiation therapy professional prior to use on a patient.
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    K Number
    K071078
    Device Name
    .DECIMAL RANGE COMPENSATOR
    Manufacturer
    .DECIMAL, INC.
    Date Cleared
    2007-05-22

    (35 days)

    Product Code
    IXI
    Regulation Number
    892.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    .DECIMAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In proton therapy for cancer, a proton beam is aimed at the cancerous tissue using a large "snout". The "snout" is rotated around the patient using a large, three-story gantry. While the patient lies on a treatment table, the gantry rotates around and points the snout at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires two custom-made, beam modifying, patient specific devices: a range compensator and an aperture. The range compensator is made out of acrylic or wax. The custom shape/design specifications for range compensators are generated out of the treatment planning system and are unique to each patient and each gantry angle (most patients will have 2-3 different gantry angles.) The outer dimensions/specifications are vendor specific, based upon the manufacturer of the proton delivery machines.
    Device Description
    .decimal's Range Compensator manufacturing service manufactures the solid Range Compensators for intensity modulation of external beam proton radiation therapy. The Range Compensator are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
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    K Number
    K071077
    Device Name
    .DECIMAL APERTURE
    Manufacturer
    .DECIMAL, INC.
    Date Cleared
    2007-05-18

    (31 days)

    Product Code
    IXI
    Regulation Number
    892.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    .DECIMAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In proton therapy for cancer, a proton beam is aimed at the cancerous tissue using a large "snout". The "snout" is rotated around the patient using a large, three-story gantry. While the patient lies on a treatment table, the gantry rotates around and points the snout at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires two custom-made, beam modifying, patient specific devices: a range compensators and apertures. The apertures are inserted into the gantry's snout to shape and focus the beam as it exits the gantry en route to the targeted area. The aperture is a brass plate with a 2D pattern/hole cut out of it, which defines the area that is to be treated with the proton beam. Apertures are generated out of the treatment planning system and are unique to each patient and each gantry angle (most patients will have 2-3 different gantry angles.) The outer dimensions/specifications are vendor specific, based upon the manufacturer of the proton delivery machines.
    Device Description
    .decimal's Aperture manufacturing service manufactures the solid apertures for intensity modulation of external beam proton radiation therapy. The apertures are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
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    K Number
    K061440
    Device Name
    P.D
    Manufacturer
    .DECIMAL, INC.
    Date Cleared
    2006-06-27

    (34 days)

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

    .DECIMAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The p.d software takes a Treatment Planning System design of a compensating filter used for radiation therapy which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface. The customer will use the software in-house before sending the file to .decimal to be manufactured. Each filter must be QA'd by the customer before use on a patient.
    Device Description
    .decimal created a software translator to be used with a Radiation Therapy Treatment Planning Systems (TPS). The software takes the TPS design of a compensating filter used for radiation therapy which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface.
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