BEUDAMED
    Product Code: NCS FDA class 2 21 CFR 892.1550

    System, Imaging, Holography, Acoustic

    Radiology

    The System, Imaging, Holography, Acoustic (product code NCS) is a radiology imaging system that uses acoustic holography to generate diagnostic images. It is classified as an FDA Class 2 device, requiring 510(k) premarket clearance to establish substantial equivalence to a legally marketed predicate device. Regulated under 21 CFR 892.1550, this device falls within the Radiology medical specialty. It is not an implant and does not carry life-sustaining or GMP-exempt designations.

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    510(k)s
    3
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    1

    Basic Information

    Product Code
    NCS
    Device Class
    FDA class 2
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K013886 AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
    K013291 ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
    K001510 OS-2000 OPTICAL SONOGRAPHY SYSTEM