Search Filters

Search Results

Found 38 results

510(k) Data Aggregation

    K Number
    K060550
    Device Name
    KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386
    Manufacturer
    EASTMAN KODAK COMPANY
    Date Cleared
    2006-03-31

    (29 days)

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

    EASTMAN KODAK COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KODAK DirectView DR 3000 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
    Device Description
    Not Found
    Ask a Question
    K Number
    K060137
    Device Name
    KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
    Manufacturer
    EASTMAN KODAK COMPANY
    Date Cleared
    2006-03-16

    (56 days)

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

    EASTMAN KODAK COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CR Systems are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiography applications. This excludes mammography applications for the Kodak Ektascan Storage Phosphor Reader and the Kodak Eclipse Image Processing Software in the United States.
    Device Description
    Not Found
    Ask a Question
    K Number
    K060079
    Device Name
    KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM
    Manufacturer
    EASTMAN KODAK COMPANY
    Date Cleared
    2006-02-08

    (29 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    EASTMAN KODAK COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KODAK CR-7400 Digital Radiography System is intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral images.
    Device Description
    Not Found
    Ask a Question
    K Number
    K060055
    Device Name
    KODAK PACS
    Manufacturer
    EASTMAN KODAK COMPANY
    Date Cleared
    2006-02-07

    (29 days)

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

    EASTMAN KODAK COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KODAK PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive/distribute/retrieve and display images and data from all hospital modalities and information systems. This includes the display of structured reports from CAD systems with DICOM "for presentation" mammography images.
    Device Description
    The KODAK PACS is an image management system.
    Ask a Question
    K Number
    K053347
    Device Name
    KODAK CARESTREAM PACS
    Manufacturer
    EASTMAN KODAK COMPANY
    Date Cleared
    2006-01-04

    (33 days)

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

    EASTMAN KODAK COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KODAK CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive/distribute/retrieve and display images and data from all hospital modalities and information systems.
    Device Description
    Not Found
    Ask a Question
    K Number
    K051483
    Device Name
    KODAK DIRECTVIEW DR SYSTEM DETECTOR
    Manufacturer
    EASTMAN KODAK COMPANY
    Date Cleared
    2005-06-21

    (15 days)

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

    EASTMAN KODAK COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KODAK DirectView DR System Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used.
    Device Description
    Not Found
    Ask a Question
    K Number
    K051258
    Device Name
    KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345
    Manufacturer
    EASTMAN KODAK COMPANY
    Date Cleared
    2005-06-01

    (16 days)

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

    EASTMAN KODAK COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KODAK DirectView DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
    Device Description
    Not Found
    Ask a Question
    K Number
    K042158
    Device Name
    KODAK MEDICAL IMAGER 300
    Manufacturer
    EASTMAN KODAK COMPANY
    Date Cleared
    2004-09-24

    (45 days)

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

    EASTMAN KODAK COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KODAK Medical Imager 300 Imager is intended use as a 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 Medical Imager 300 and transformed thermally to develop Eastman Kodak imaging media. The system of printer and physical image is intended for use with a variety of modalities, including, but not limited to CR, DR, CT, MRI, Ultrasound, Nuclear Medicine, etc. for diagnostic use by medical radiologists and communications to referring physicians and their patients. The system of printer and physical image is not a high resolution device and is not intended for use with FFDM systems.
    Device Description
    The imagers receive image data from the modality. User control is performed directly by the modality or through the host control. KODAK imaging media is removed from a cartridge and transported to the imaging station. Image data addresses the individual pixel elements in the thermal print head. The heat of the thermal head reacts the thermally sensitive film to produce the image and the film exits the printer. Software is used to control the image management and machine functions. AIQC (Automated Image Quality Control) matches printing power with film characteristics to provide consistently high image quality.
    Ask a Question
    K Number
    K042159
    Device Name
    KODAK COLOR MEDICAL IMAGER 1000
    Manufacturer
    EASTMAN KODAK COMPANY
    Date Cleared
    2004-09-24

    (45 days)

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

    EASTMAN KODAK COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kodak Color Medical Imager 1000 series medical printers are thermal print engines intended to produce continuous tone photographic quality hard copy output with integrated color management that adjusts printed colors to accurately match medical image monitors or user specified color profiles. The hardcopy output includes, however is not limited to, nuclear medicine, ultrasound, CT (especially 3-D reconstruction), MRI and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral. Digital images can be acquired from, but not limited to local area networks (LAN), Internet, medical image storage devices, or directly from digital medical image capture modalities. The system of printer and physical image is not a high-resolution device and is not intended for use with FFDM systems.
    Device Description
    The KODAK Color Medical Imager 1000 is intended for use as a hard copy device for output from imaging source modalities used in medical imaging diagnosis and referral. Electronic image information signals are managed in the KODAK Color Medical Imager 1000 and transformed to heat a color donor ribbon and drive color dyes to a receptor sheet using thermal dye sublimation technology.
    Ask a Question
    K Number
    K040378
    Device Name
    KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253
    Manufacturer
    EASTMAN KODAK COMPANY
    Date Cleared
    2004-05-24

    (97 days)

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

    EASTMAN KODAK COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KODAK DirectView CR cassette holds a storage phosphor screen which is exposed by radiographic equipment for the recording of a patient radiation pattern. The cassette is loaded into a compact laser scanner capable of reading the latent image. The Kodak DirectView CR 15 x 30 cm cassette and storage phosphor screen can be used for general radiology and dental panoramic radiography applications.
    Device Description
    The Kodak DirectView CR 15 x 30 cm cassette size is designed to perform general radiography and panoramic dental exams when used with the Kodak DirectView CR 850 and CR 950 systems. The cassette system (cassette and storage phosphor screen adhered to the cassette plate) can be used in common dental panoramic x-ray dental units designed to accept cassettes that meet the ISO 4090 standard. The CR cassette is a standard x-ray diagnostic cassette used for computed radiography. The panel materials are consistent with the current design of the CR cassette and include Corus Hylite and Toray Panel. The Corus Hylite panel includes two lavers of aluminum, with polypropylene (plastic) in the middle, and is covered with Omnova (clear viny) with printing on the second surface). On the tube side of the cassette there is Toray Carbon Fiber Panel that consists of four layers of carbon fiber. The storage phosphor plate is attached to the honeycomb panel. The lead mylar that is in place under the phosphor layer of the screen was removed in the CR 15 x 30 cm cassette in order to accommodate Automatic Exposure Control (AEC) in dental x-ray units.
    Ask a Question

    Page 1 of 4