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510(k) Data Aggregation

    K Number
    K163063
    Device Name
    UC-5000 Mobile X-Ray
    Manufacturer
    SOURCE-RAY, INC.
    Date Cleared
    2016-12-12

    (40 days)

    Product Code
    IZL, MQB
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOURCE-RAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UC-5000 Mobile X-Ray is intended for General Purpose Radiographic exams utilizing film, computed radiography, or direct digital flat panels. Not for mammography.
    Device Description
    The UC-5000 Mobile X-Ray consists of an X-ray generator, continuously adjustable light beam collimator, mounting arm, exposure cord with exposure switch, and AC power cord. This is a high-frequency generator of updated design. Light Weight (no batteries) No Special Power Requirements (115/220 VAC Power Input) High Frequency 5.0 kW Generator with Closed loop regulation Digital Displays: kVp, mA, mAs & exposure time. Optionally available with the system is an FDA cleared digital panel and software combination.
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    K Number
    K133959
    Device Name
    PODIATRY X-RAY SYSTEM
    Manufacturer
    SOURCE-RAY, INC.
    Date Cleared
    2015-01-22

    (394 days)

    Product Code
    KPR, MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOURCE-RAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model PXS-710D X-Ray System is intended for General Purpose Podiatry Radiographic Applications.
    Device Description
    Not Found
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    K Number
    K090655
    Device Name
    PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260
    Manufacturer
    SOURCE-RAY, INC.
    Date Cleared
    2009-07-14

    (125 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOURCE-RAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model PowerMax 1260 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications
    Device Description
    Not Found
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    K Number
    K071392
    Device Name
    PXS-810, PODIATRY X-RAY SYSTEM
    Manufacturer
    SOURCE-RAY, INC.
    Date Cleared
    2007-08-03

    (77 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOURCE-RAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model PXS-810 Podiatry X-Ray System is intended for General Purpose Podiatry Radiographic Applications.
    Device Description
    Not Found
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    K Number
    K062472
    Device Name
    OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115
    Manufacturer
    SOURCE-RAY, INC.
    Date Cleared
    2006-10-31

    (68 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOURCE-RAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.
    Device Description
    Not Found
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    K Number
    K052001
    Device Name
    MODEL SR-115 PORTABLE X-RAY SYSTEM
    Manufacturer
    SOURCE-RAY, INC.
    Date Cleared
    2005-08-11

    (17 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOURCE-RAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.
    Device Description
    X-Ray System, Portable
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    K Number
    K043062
    Device Name
    MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM
    Manufacturer
    SOURCE-RAY, INC.
    Date Cleared
    2004-12-13

    (38 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOURCE-RAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model SR-130-D Digital Portable X-Ray System is The Model OR Too E Portable Radiographic Applications.
    Device Description
    Not Found
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    K Number
    K030494
    Device Name
    SR-130
    Manufacturer
    SOURCE-RAY, INC.
    Date Cleared
    2003-05-20

    (90 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOURCE-RAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model SR-130 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.
    Device Description
    Not Found
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