BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PEARL INC.

    Reg #: 3021887566 · FEI: 3021887566 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    PEARL INC.
    Registration Number
    3021887566
    FEI Number
    3021887566
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9200 W Sunset Blvd Ste 430
    City
    West Hollywood
    State
    CA
    ZIP
    90069
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242522

    Owner / Operator

    Firm Name
    Pearl Inc.
    Operator Number
    10084584
    Address
    9200 Sunset Blvd, Suite 430
    City
    West Hollywood
    State
    CA
    Postal Code
    90069
    Country
    US
    Correspondent
    Ashley Brown

    Products

    Device Name Product Code
    Analyzer, Medical Image MYN
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    Second Opinion Second Opinion CC Second Opinion Pediatric Second Opinion Panoramic Second Opinion CS Second Opinion Periapical Radiolucency Contours Second Opinion 3D Second Opinion BLE

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198