BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Soteria.AI

    K Number: K212336 · Decision Nov 17, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    319
    Applicant Total
    7
    Review Days
    113

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    Basic Information

    Device Name
    Soteria.AI
    K Number
    K212336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omega Medical Imaging, LLC
    Date Received
    July 27, 2021
    Decision Date
    November 17, 2021
    Product Code
    OWB
    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
    OWB Interventional Fluoroscopic X-Ray System

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    Other Clearances by Omega Medical Imaging, LLC

    K Number Device Name
    K242488 Soteria E-View
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    K191713 CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)
    K182834 CS-series-FP with Optional ROI Accessory CA-100S
    K171755 CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
    K121293 CS-SERIES-FP WITH 3030+OPTION