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510(k) Data Aggregation

    K Number
    K101039
    Device Name
    SHIMADZU COLLIMATOR R-300
    Manufacturer
    SHIMADZU CORP.
    Date Cleared
    2010-09-20

    (159 days)

    Product Code
    IZW
    Regulation Number
    892.1610
    Why did this record match?
    Product Code :

    IZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used in radiology. This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area. This device is for diagnostic use.
    Device Description
    This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view.
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    K Number
    K093572
    Device Name
    R650 QDASM COLLIMATOR
    Manufacturer
    OMEGA MEDICAL IMAGING, INC.
    Date Cleared
    2010-02-03

    (77 days)

    Product Code
    IZW
    Regulation Number
    892.1610
    Why did this record match?
    Product Code :

    IZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omega R650 QDASM automatic beam limiting device is intended for use in X-ray diagnostic radiographic/fluoroscopic applications.
    Device Description
    The Omega R 650 QDASM is an automatic beam limiting device designed for use in diagnostic radiographic/fluoroscopic applications. It includes square field shutters, spectral filters, and an additional lung filter for cardiac application. This device is substantially equivalent to the predicate devices with respect to technological characteristics.
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    K Number
    K090578
    Device Name
    SHIMADZU COLLIMATOR R-30H
    Manufacturer
    SHIMADZU CORP.
    Date Cleared
    2009-11-06

    (248 days)

    Product Code
    IZW
    Regulation Number
    892.1610
    Why did this record match?
    Product Code :

    IZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The R-30H is used to take the radiography of patients. The intended for use of the R-30H are also the same as of the predicate beam limiting device R-30H (K031771).
    Device Description
    Not Found
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    K Number
    K091517
    Device Name
    RALCO, MODEL R225 ACS
    Manufacturer
    RALCO S.R.L.
    Date Cleared
    2009-07-14

    (53 days)

    Product Code
    IZW
    Regulation Number
    892.1610
    Why did this record match?
    Product Code :

    IZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Model R225 ACS Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
    Device Description
    This x-ray collimator Multilayer, square-field, automatic collimation system. Stepper motors control the movements of shutters and the additional filter. There is a mounting plane at 80 mm (3.15") from the focus. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The field dimensions may be decreased and increased to the set value by two knobs placed on the collimator front panel.
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    K Number
    K083029
    Device Name
    MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR
    Manufacturer
    RALCO S.R.L.
    Date Cleared
    2008-12-05

    (56 days)

    Product Code
    IZW
    Regulation Number
    892.1610
    Why did this record match?
    Product Code :

    IZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Model R605DASM Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
    Device Description
    This device is a compact radiological automatic collimating system for round and elliptic fields designed to operate with a mobile "C" arm Image Intensifier cquipment. The round and elliptical fields are defined as follows: The round field by 8 lead shutters located near the exit window and a brass cone near the x-ray focus; the elliptical field by the round field and two pairs of lead rectangular shutters located near the collimator entrane window. Round and elliptical field shutters are controlled by 5 stepping motors. The circlinator features a microprocessor circuit built into the collimator to control the 5 stepping-motornia external signal source with CanBus protocol. The circuits return a CanBus protocol signal to indicate correct motor positioning. The two pairs of lead rectangular shutters move isignify and both rotate ± 360° ..
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    K Number
    K072780
    Device Name
    MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR
    Manufacturer
    RALCO S.R.L.
    Date Cleared
    2007-11-26

    (59 days)

    Product Code
    IZW
    Regulation Number
    892.1610
    Why did this record match?
    Product Code :

    IZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Model R302DACS/A Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
    Device Description
    Model R302DACS/A Automatic X-RAY Collimator is an Automatic X-ray beam-limiting system with a multilayer square field collimator. Stepper motors drive shutter movements as well as additional filters and the round field if these two features are mounted. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The two stepper motors that provide shutter control may also be manually adjusted by the two knobs or by the pushbuttons located on the front panel. Two boards built into the collimator allow direct control of the system via CAN-Bus protocol.
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    K Number
    K073124
    Device Name
    COLLIMARE COLLIMATOR FAMILY
    Manufacturer
    COLLIMARE, LLC
    Date Cleared
    2007-11-16

    (10 days)

    Product Code
    IZW
    Regulation Number
    892.1610
    Why did this record match?
    Product Code :

    IZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment during radiographic and fluoroscopic procedures. It is designed to be adapted to various x-ray systems.
    Device Description
    The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment. The intended usage is all portable/fixed, manual and automatic, Radiographic, Fluoroscopic, rectangular, square and/or circular shuttering. It can encompass a light simulation, spectral filters, wedge filters, input port shuttering, dose measurement, laser alignment indicating lines and/or mechanical or digital SID measurement.
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    K Number
    K050092
    Device Name
    R605 FACS COLLIMETER
    Manufacturer
    OMEGA MEDICAL IMAGING, INC.
    Date Cleared
    2005-01-31

    (17 days)

    Product Code
    IZW
    Regulation Number
    892.1610
    Why did this record match?
    Product Code :

    IZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omega R605 FACS automatic collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
    Device Description
    The Omega R 605FACS is an automatic collimator designed for use in diagnostic Trie Offically of tool AOO is an adtomatio continues round field shutters and an additional lung filter for cardiac application.
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    K Number
    K031597
    Device Name
    DUNLEE FORMAT COLLIMATOR FAMILY
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
    Date Cleared
    2003-07-21

    (61 days)

    Product Code
    IZW
    Regulation Number
    892.1610
    Why did this record match?
    Product Code :

    IZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dunlee "FORMAT" collimator family restricts the dimensions of the diagnostic X-rav field by limiting the size of the primary X-ray beam. The Dunlee manual "FORMAT M" collimators are intended for use in diagnostic X-ray systems during radiographic examinations. The Dunlee automatic "FORMAT A" collimators are intended for use in diagnostic X-ray systems during radiographic and fluoroscopic examinations.
    Device Description
    The Dunlee "FORMAT" collimator family is a family of Beam-Limiting Devices, which comprises both manual and automatic collimators. The manual collimators are to be used in diagnostic radiographic X-ray systems, and the automatic collimators are to be used in both diagnostic fluoroscopy X-ray systems and diagnostic radiographic X-ray systems.
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    K Number
    K990423
    Device Name
    PHILIPS NICOL COLLIMATOR FAMILY
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Date Cleared
    1999-03-15

    (32 days)

    Product Code
    IZW
    Regulation Number
    892.1610
    Why did this record match?
    Product Code :

    IZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Philips NICOL Collimator is intended for use in diagnostic x-ray systems during radiographic and fluoroscopic examinations. The collimator restricts the dimensions of the diagnostic x-ray field by limiting the size of the primary x-ray beam.
    Device Description
    The NICOL collimator family of Beam Limiting Devices which may be used in all Philips Radiographic, Universal Radiographic/Fluoroscopic, Cardio and Vascular systems. It will provide rectangular shuttering, circular shuttering, or a combination of both. It will provide a light simulation of the X-ray field, spectral filtering, wedge filtering, dose measurement, and mechanical or electronic SID measurement.
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