Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K203244
    Device Name
    CellChek 20 rc
    Manufacturer
    Konan Medical, Inc.
    Date Cleared
    2021-06-15

    (224 days)

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

    Konan Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CellChek 20 rc is a software program intended to analyze ophthalmic images captured by the Konan Specular Microscope XVII for examination of corneal endothelium.
    Device Description
    Konan Medical has developed the CellChek 20 rc to provide photographic data taken exclusively by the Konan Specular Microscope XVII, CellChek 20, which was cleared by FDA under 510(k) number K191558 on Mar 26, 2020, to research and learning centers for the advancement of ophthalmic sciences and practice. The CellChek 20 rc was developed based on the software program of CellChek 20. CellChek 20 rc is a software program to analyze ophthalmic images for examination of corneal endothelium. This has the cell counting analysis program, and allows for analysis of the images of the cell distribution of the eye. The software program is installed on a general-use computer to analyze corneal endothelial images photographed exclusively by the Konan Specular Microscope XVII, CellChek 20. The analysis function is to calculate mainly the cell density, the coefficient of variation of cell area, and the percent hexagonality. In the manual methods, cornea endothelial cells and cell boundaries are actually identified by users. In the automatic methods, this software detects cells and cell boundaries, however, users can modify the detection results. During operating, the users interact with the software by visually placing dots in the center of each of cells and/or by tracing cell boundaries displayed on a computer screen, or use the automatic algorithm.
    Ask a Question
    K Number
    K191558
    Device Name
    Konan Specular Microscope XVII
    Manufacturer
    Konan Medical, Inc.
    Date Cleared
    2020-03-26

    (288 days)

    Product Code
    NQE
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Konan Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Konan Specular Microscope XVII, CellChek 20, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.
    Device Description
    The Konan Specular Microscope XVII, CellChek 20, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea. Cell counting and analysis program are included, and allow for analysis of the images of the cell distribution of the eye. When photographing the corneal endothelium, the device performs the alignment and automatically focuses by capturing the reflected light from patient's eye with the camera. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, as well as computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory and can be preserved by using a printer. The parts of the device that come into contact with a patient are the forehead rest and the chin rest. Their material is acrylonitrile butadiene styrene (ABS), the same material used in reference device and one with proven biocompatibility. The function of the software installed in the device is to calculate mainly the cell density, the coefficient of variation of cell area and the percent hexagonality. In the manual methods, Actual identification if the cells and cell boundaries is done by the (physician) user. In the automatic method, the software detects the cells and cell boundaries, however, the user is given the opportunity to make corrections. In use, the user interacts with the software by visually placing dots in the center of cells as or by tracing cell boundaries as they appear or on a screen or uses the automatic algorithm.
    Ask a Question
    K Number
    K120264
    Device Name
    KONAN SPECULAR MICROSCOPE XIV
    Manufacturer
    KONAN MEDICAL, INC.
    Date Cleared
    2012-04-11

    (72 days)

    Product Code
    NQE, NOE
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    KONAN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Konan Specular Microscope XIV, Cellchek Plus, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.
    Device Description
    The Konan Specular Microscope XIV, CellChek Plus, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. Cell counting and analysis programs are included, and allow for analysis of the cell distribution of the eye (the same analysis software present in the predicate device is also present in the modified device). When photographing the corneal endothelium, the equipment performs the alignment and automatically focuses by capturing the reflected light from the patient's eye with the CCD camera. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory, and are preserved by using a printer. Both the image of the corneal endothelium and the various computerized control functions are displayed on the touch screen. The parts of the device that come into contact with a patient are the forehead rest and the chin rest. The head rest is comprised of Polytetrafluoroethylene (PTFE), which is known as Teflon®, and the material that comprises the chin rest is Acrylonitrile butadiene styrene (ABS).
    Ask a Question
    K Number
    K081797
    Device Name
    IMAGE STORAGE SYSTEM, MODEL KSS-400
    Manufacturer
    KONAN MEDICAL, INC.
    Date Cleared
    2009-01-22

    (211 days)

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

    KONAN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KSS-400 Image Storage System is a software product intended to be used for automatic image analysis and data storage for corneal images taken with Specular Microscopes The program analyzes cell density, coefficient of variation, and hexagonality using images taken by the specular microscopes
    Device Description
    The KSS 400 Image Storage System is a software product that permits users to analyze corneal images made by Konan specular microscopes in a separate computer and to store them in the computer's memory
    Ask a Question
    K Number
    K062763
    Device Name
    NONCON ROBO PACHY F&A
    Manufacturer
    KONAN MEDICAL, INC.
    Date Cleared
    2008-02-22

    (525 days)

    Product Code
    NQE
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    KONAN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Noncon Robo Pachy F&A is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea.
    Device Description
    The Noncon Robo Pachy F&A specular microscope and optical pachymeter is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. It is an improvement to the original Konan Noncon Robo Pachy, K980357. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photographic images are temporarily stored in the system's memory, and are preserved in video form on magnetic tape or by using a video printer. The memory can store two endothelial cell images and two anterior segment images, which are usually those of the left and right eyes.
    Ask a Question
    K Number
    K040373
    Device Name
    KERATO ANALYZER (EKA)
    Manufacturer
    KONAN MEDICAL, INC.
    Date Cleared
    2004-03-19

    (31 days)

    Product Code
    NQE
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    KONAN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Konan Kerato Analyzer ("EKA") is a specular microscope used to make cell counts of preserved corneas in eye banks and to measure the thicknesses of the corneas without removing the corneas from their storage vials.
    Device Description
    The Konan Kerato Analyzer ("EKA") is a specular microscope used to make cell counts of prescrved corneas in eye banks and to measure the thicknesses of the corneas without removing the corneas from their storage vials. The basic structure of the EKA is similar to that of an inverted laboratory microscope. With the EKA, all focusing is done manually by the operator. For the EKA, vials containing the corneas are placed in a receptacle in the unit.
    Ask a Question

    Page 1 of 1