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510(k) Data Aggregation

    K Number
    K992229
    Device Name
    MXU-125 OR TMX-125
    Manufacturer
    Date Cleared
    1999-08-06

    (35 days)

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

    TREX MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MXU-125 or TMX-125 is a Mobile x-ray Unit intended for use in general radiographic medical procedures by a licensed professional.
    Device Description
    The Mobile X-ray Unit is a portable, battery-powered, self-propelled - unit - designed - for - making - film radiographs in a hospital environment. The unit is capable of generating diagnostic x-rays according to the technique factor combinations selected and controlled by the operator.
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    K Number
    K984091
    Device Name
    CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000
    Manufacturer
    Date Cleared
    1999-02-05

    (81 days)

    Product Code
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    TREX MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Contour 2000 Mammography system, Model CTR-2000, is used for dedicated mammographic examination
    Device Description
    The Bennett Contour 2000 Mammographic System, Model CTR-1. 2000, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations. The CTR-2000 is adaptable to performing screening and/or biopsy procedures with the addition of either a film-based or digital-based image receptor device attached. It consists of the following components; an x-ray generator cabinet, Model M-2000G (single-phase input) or Model M-2000G-3P (three-phase input); a tube stand with a tilting c-arm; mammographic collimator (DM-2000) and tube; an operator control panel, Model M-2000C; and image receptor (film cassette holder or bucky). The Contour 2000 Mammography System is a microprocessor-controlled x-ray source requiring single-phase 200-240 VAC, 50/60 Hz or three-phase 208-440 VAC, 50/60 Hz for operation. The Contour 2000 system's c-arm is fully counterbalanced and is locked in position using electro-mechanical locks. The c-arm has a fixed source-to-image distance (SID) of 76 cm.
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    K Number
    K984092
    Device Name
    PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000
    Manufacturer
    Date Cleared
    1999-02-05

    (81 days)

    Product Code
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    TREX MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    THE PROFILE 2000 MAMMOGRAPHY SysTEM, MODEL PRO-2000, 15 A DEDICATED MANMOGRAPHIC IMAGING SysTEM USED FOR MAMMOGRAPHIC EXAMINATIONS.
    Device Description
    The Bennett Profile 2000 Mammographic System, Model PRO-1. 2000, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations. The PRO-2000 is adaptable to performing screening and/or biopsy procedures with the addition of either a film-based or digital-based image receptor device attached. It consists of the following components; an x-ray generator cabinet, Model M-2000G (single-phase input) or Model M-2000G-3P (three-phase input); a tube stand with a non-tilting c-arm; mammographic collimator (DM-2000) and tube; an operator control panel, Model M-2000C; and image receptor (film cassette holder or bucky). The Profile 2000 Mammography System is a microprocessor-controlled x-ray source requiring single-phase 200-240 VAC, 50/60 Hz or three-phase 208-440 VAC, 50/60 Hz for operation. The Profile 2000 system's c-arm is fully counterbalanced and is locked in position using electro-mechanical locks. The c-arm has a fixed source-to-image distance (SID) of 76 cm.
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    K Number
    K984414
    Device Name
    XRE COLLIMATOR WITH SPECTRAL FILTER
    Manufacturer
    Date Cleared
    1998-12-30

    (20 days)

    Product Code
    Regulation Number
    892.1610
    Why did this record match?
    Applicant Name (Manufacturer) :

    TREX MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The XRE Collimator with spectral filter is designed to be the primary X-ray beam limiting device as part of an angiographic imaging system and is controllable manually and automatically. It also provides a means of manual or automatic selection of filtration designed to reduce the xray dose applied to the patient while still providing high quality images. It is designed to be operated by professional medical personnel only.
    Device Description
    Not Found
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    K Number
    K982427
    Device Name
    TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C
    Manufacturer
    Date Cleared
    1998-09-23

    (72 days)

    Product Code
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    TREX MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TREX Tilt-C, Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system. It is an all-digital multi-purpose system designed to address a broad variety of radiographic/fluoroscopic, interventional and limited angiographic procedures.
    Device Description
    Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system, Model TREX Tilt-C. It is an all-digital multi-purpose system designed to address a broad variety of radiographic/fluoroscopic, interventional and limited angiographic procedures.
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    K Number
    K982120
    Device Name
    DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)
    Manufacturer
    Date Cleared
    1998-09-10

    (86 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    TREX MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Digital Imaging System, Model DigiTREX-X000 is a digital video processing system and is intended to be produced by the radiographic, fluoroscopic, or special procedure systems, excluding mamography.
    Device Description
    Digital Imaging System, Model DigiTrex-1000 and DigiTrex-2000 is a digital video processing system.
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