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510(k) Data Aggregation

    K Number
    K200516
    Device Name
    OCT-Camera ID 21101A3
    Manufacturer
    OptoMedical Technologies GmbH
    Date Cleared
    2020-09-02

    (184 days)

    Product Code
    OBO
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    OptoMedical Technologies GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OptoMedical Technologies OCT-Camera ID 21101A3 is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT). The OCT-Camera ID 21101A3 is indicated for the use as an aid in the diagnosis of physiologic conditions of the eye through non-contact optical imaging. Imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on all patient populations except premature and is suitable for patients ambulatory or confined. The system is indicated for use in supine imaging, mounted to the surgical microscope HS Hi-R NEO 900A NIR (Haag-Streit), and is suited for imaging patients under anesthesia.
    Device Description
    The OCT-Camera ID 21101A3 can connected via the camera port of surgical microscopes. The OCT-Camera ID 21101A3 is completely integrated into the surgical procedure by enabling the OCT imaging before, during, and after microsurgery without disrupting the microscopic view. Individual steps of surgical procedures can be visualized in real time. The OCT-Camera ID 21101A3 by OptoMedical Technologies GmbH facilitates the intraoperative use of OCT (iOCT). It is called OCT-Camera ID 21101A3, because it can be attached to the camera port of an operating microscope like any common camera that are used for the purpose of providing live view images of the surgical field.
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    K Number
    K142953
    Device Name
    OCT-Camera
    Manufacturer
    OptoMedical Technologies GmbH
    Date Cleared
    2015-03-04

    (145 days)

    Product Code
    HLI, OBO
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    OptoMedical Technologies GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OptoMedical Technologies OCT-Camera is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT). The OCT-Camera is indicated for the use as an aid in the diagnosis of physiologic conditions of the eye through non-contact optical imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on patient populations from premature and neonatal infants to adult, and is suitable for patients ambulatory or confined. The system is indicated for use in supine imaging, mounted to a surgical microscope HS Hi-R NEO 900A NIR (Haag-Streit), and is suited for imaging patients under anesthesia.
    Device Description
    The OCT-Camera can be attached to the camera port of surgical microscopes. The OCT-Camera is completely integrated into the surgical procedure by enabling the OCT imaging before, during, and after microsurgery without disrupting the microscopic view. The individual steps and the outcome of the surgical procedures, such as transplantation of the thin membranes or micro implants, are visualized in real time. The OCT-Camera by OptoMedical Technologies GmbH facilitates the intraoperative use of OCT (iOCT). It is called OCT-Camera because it can be attached to the camera port of an operating microscope like any common camera that are used for the purpose of providing live view images of the surgical field.
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