BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SPECTRAL MD, INC.

    Reg #: 3011050541 · FEI: 3011050541 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SPECTRAL MD, INC.
    Registration Number
    3011050541
    FEI Number
    3011050541
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2515 McKinney Ave Ste 1000
    City
    Dallas
    State
    TX
    ZIP
    75201
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN250028

    Owner / Operator

    Firm Name
    Spectral MD, Inc.
    Operator Number
    10047254
    Address
    2515 McKinney Ave., Suite 1000
    City
    Dallas
    State
    TX
    Postal Code
    75201
    Country
    US
    Correspondent
    Trudy D Estridge

    Products

    Device Name Product Code
    Tape, Camera, Surgical FXN
    Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment. SHY

    Proprietary Names

    DeepView AI® System

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device