BEUDAMED
    Product Code: EGW FDA class 2 21 CFR 892.1900

    Dryer, Film, Radiographic

    Radiology

    The Radiographic Film Dryer is a device used in radiology and dental imaging facilities to remove moisture from processed radiographic film, accelerating the drying step after chemical development and enabling faster film handling. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is EGW, regulated under 21 CFR 892.1900 in the Radiology (RA) specialty.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    14

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    Basic Information

    Product Code
    EGW
    Device Class
    FDA class 2
    Regulation Number
    892.1900
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    4

    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K902531 EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL
    K760846 PAKOSTAT II