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510(k) Data Aggregation

    K Number
    K981280
    Device Name
    CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS
    Manufacturer
    BAYER CORP., AGFA DIV.
    Date Cleared
    1998-04-30

    (22 days)

    Product Code
    IXW
    Regulation Number
    892.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    BAYER CORP., AGFA DIV.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To process (develop) medical imaging films for viewing by physicians. This may be used in the imaging modalities of Ultrasound, X-Ray, Nuclear Medicine, Computed Tomography, Mammography, Cardiology, and Magnetic Resonance.
    Device Description
    All currently marketed automatic film processors have the same basic components, including a feed and detection mechanism, a processing system consisting of chemical tanks and transport racks, a washer, a dryer, a receiving bin, and controls and indicators. Major subsystems include water supply, temperature regulation, chemical replenishment, and solution circulation. The device performs standard photographic processing of previously exposed sheets or rolls of silver-halide based films. The processed films contain acquired anatomical images for viewing by physicians, typically of the radiological discipline specialty. The photographic processing (developing) technique employed by these automatic processors is the same as all devices manufactured by several companies, and has gone basically unchanged in approximately fifteen years. The film medium is mechanically transported for immersion in two chemical baths (developer and fixer), is rinsed in water, dried, and then ejected for viewing and archival purposes. The Agfa family of automatic film processors also offers additional features such as daylight handling and processing, laser film recorder docking, and automatic film handling for various types and sizes of imaging films used in the above radiographic applications. Some models offer the E.O.S. (Environmentally Optimized System) feature. This feature employs an additional fixer tank technique that reduces fixer solution consumption and waste.
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    K Number
    K974597
    Device Name
    ADC COMPACT (AGFA DIAGNOSTIC CENTER)
    Manufacturer
    BAYER CORP., AGFA DIV.
    Date Cleared
    1998-03-09

    (90 days)

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

    BAYER CORP., AGFA DIV.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide diagnostic quality images for aid in physician diagnosis. This is used in the X-Ray imaging modality, mainly in Chest, Skeleton, and Gastro-Intestinal imaging applications.
    Device Description
    The ADC COMPACT is a Computed Radiography Imaging System. This system replaces conventional X-Ray cassettes that contain one or two intensifying screens and photographic light sensitive film. Computed radiography utilizes filmless cassettes. Instead of screens and photographic film to obtain the diagnostic image, the system employs what is termed as an imaging plate. This plate is coated with photo stimulatable storage phosphors that are sensitive to the X-Ray energy, and capable of retaining a latent image. This imaging plate is inserted into a device that scans it and releases the latent image in the form of light which is converted into a digital bit stream. This bit stream of image data is stored, and introduced to the PACS (Picture Archiving and Computerized System) network in DICOM format. The major difference between the ADC COMPACT and the previous model in commercial distribution is the actual physical size of the portion of the system that reads and digitizes the imaging plates.
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    K Number
    K964414
    Device Name
    LR 5200 LASER FILM RECORDER
    Manufacturer
    BAYER CORP., AGFA DIV.
    Date Cleared
    1997-01-27

    (83 days)

    Product Code
    LMC
    Regulation Number
    892.2040
    Why did this record match?
    Applicant Name (Manufacturer) :

    BAYER CORP., AGFA DIV.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The diseases and conditions that the device will aid in the diagnosis of, are those that are typical to radiological types of examinations.
    Device Description
    The LR 5200 is a laser based (Helium-neon) film recorder, designed for producing high quality gray scale diagnostic medical images, when interfaced to a host imaging device. Typical host imaging devices would include those of Magnetic Resonance, Computed Tomography, Ultrasound, Mammography, Digital Radiography, and Nuclear Medicine imaging modalities.
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