BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Optellum Virtual Nodule Clinic, Optellum software, Optellum platform

    K Number: K202300 · Decision Mar 5, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    204

    Basic Information

    Device Name
    Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
    K Number
    K202300
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2060
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optellum Ltd
    Date Received
    August 13, 2020
    Decision Date
    March 5, 2021
    Product Code
    POK
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (POK), ordered by most recent decision date.

    StrokeSENS ASPECTS Software Application

    FDA 510(k)
    FDA Class 2 ·Radiology

    Fetal EchoScan (v1.1)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sonio Suspect

    FDA 510(k)
    FDA Class 2 ·Radiology

    Brainomix 360 e-ASPECTS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Koios DS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Fetal EchoScan

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all