BEUDAMED
    Product Code: QNK FDA class 3

    Optoacoustic Imaging System

    Unknown

    The Optoacoustic Imaging System is a diagnostic imaging device indicated for imaging the breast using optoacoustic technology to aid in breast cancer diagnosis, combining laser light and ultrasound detection to generate high-resolution images of breast tissue. This device is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA), with no regulation number assigned. Product code QNK, reviewed by the Radiology panel. The device is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QNK
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    RA
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.