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510(k) Data Aggregation

    K Number
    K984252
    Device Name
    IMATION TRIMATIC DIGITAL SYSTEM
    Manufacturer
    IMATION CORP.
    Date Cleared
    1999-01-25

    (59 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMATION CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Imation™ Trimatic™ Digital System is intended for use an automated system to convert radiographic films into a DICOM format image for use in a hospital or other clinical Image Management System(IMS). The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-ray films.
    Device Description
    The Imation™ Trimatic™ Digital System is intended for use as a system to convert radiographic films into a digitized format for use in a hospital or other clinical image management system. The digitized image receives patient and exam information and is then forwarded into a DICOM compliant image management system. The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-rays.
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    K Number
    K980722
    Device Name
    TRIMAX RADIOGRAPHIC CASSETTE
    Manufacturer
    IMATION CORP.
    Date Cleared
    1998-03-23

    (27 days)

    Product Code
    IXA
    Regulation Number
    892.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMATION CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Imation Trimax Cassettes are intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.
    Device Description
    Imation Trimax Cassettes are intended for use during diagnostic x-ray procedures to hold radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film. The cassettes are in a family of film sizes. The Trimax C-1 series contain a window that permits writing by a radiographic film marking system. The Trimax C-2 series is windowless. Radiologic cassettes are comprised of a light-tight chamber for preventing radiologic film exposure, a compressible backplate material to assure intimate film screen contact, a latching mechanism for removal and replacement of radiographic film, a patientoriented surface transparent to x-ray energy, lead shielding to prevent unwanted exposure to stray x-ray energy and suitable support structure for durability of the assembly.
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    K Number
    K973303
    Device Name
    IMATION MODEL 9410 NETWORK INTERFACE
    Manufacturer
    IMATION CORP.
    Date Cleared
    1997-11-25

    (83 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMATION CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Imation™ MODEL 9410 NETWORK INTERFACE Network Interface is intended for use as a communications gateway. It accepts input from imaging source modalities and transfers the image data to a compatible printing, viewing, archive or network system. The MODEL 9410 NETWORK INTERFACE accepts input in DICOM standard, digital or video formats and converts, if needed, to DICOM Standard or other digital formats. The system is intended for use with a variety of imaging modalities including CT, MR and CR for the transmission of image data to a variety of printing, viewing and storage devices.
    Device Description
    The Imation™ MODEL 9410 NETWORK INTERFACE Network Interface is intended for use as a communications gateway. It accepts input from imaging source modalities and transfers the image data to a compatible printing, viewing, archive or network system. The MODEL 9410 NETWORK INTERFACE accepts input in DICOM standard, digital or video formats and converts, if needed, to DICOM Standard or other digital formats. The system is intended for use with a variety of imaging modalities including CT, MR and CR for the transmission of image data to a variety of printing, viewing and storage devices.
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    K Number
    K972163
    Device Name
    IMATION SE-196 LASER IMAGER
    Manufacturer
    IMATION CORP.
    Date Cleared
    1997-09-05

    (88 days)

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

    IMATION CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Imation™ SE-196 laser imager is intended use as a high quality hard copy device for output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the SE-196 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities including CT, MR and CR for diagnostic use by medical radiologists and communications to referring physicians and their patients.
    Device Description
    The Imation SE-196 Laser Imager provides high quality hard copy film output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the SE-196 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities including CT, MR and CR for diagnostic use by medical radiologists and communications to referring physicians and their patients.
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    K Number
    K962750
    Device Name
    3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR
    Manufacturer
    IMATION CORP.
    Date Cleared
    1996-08-21

    (37 days)

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

    IMATION CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3M Trimatic™ Modular Advanced Processing System is an automatic, modular system for unloading exposed x-ray film from x-ray film cassettes, processing the film, and reloading the empty x-ray film cassette with fresh x-ray film of the same size and type. This system is used for handling and processing of x-ray films from all general radiographic, diagnostic procedures which employ conventional x-ray film / screen technology. The integrated automatic x-ray film processor can also be used as a stand-alone processor.
    Device Description
    The 3M Trimatic™ Modular Advanced Processing System is an automatic, modular system for unloading exposed x-ray film from x-ray film cassettes, processing the film, and reloading the empty x-ray film cassette with fresh x-ray film of the same size and type. The 3M Trimatic™ Modular APS will accommodate from four to seven different film types / sizes in film modules. The integrated automatic x-ray film processor in the subject device uses mechanical rollers and guides, chemical replenishment and chemical agitation methods. The software used to control the operation of the subject device has added capabilities over the software used in the predicate device. Encoded in the bar codes on the x-ray film cassettes are the x-ray film size, type and the correct processing conditions for that particular film. This information drives the operation of the device. Remote diagnostics via phone line is also an added feature in the subject device. The control panel controls both the load / unload process and the automatic x-ray film processor.
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