BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    RetCam Envision

    K Number: K203500 · Decision Apr 13, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    155
    Applicant Total
    12
    Review Days
    134

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    RetCam Envision
    K Number
    K203500
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1120
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
    Date Received
    November 30, 2020
    Decision Date
    April 13, 2021
    Product Code
    HKI
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HKI Camera, Ophthalmic, Ac-Powered

    Similar 510(k) Clearances

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

    Eyer 2

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Fundus On Phone Non Mydriatic (FOP NM-10)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Optina-4C (MHRC-C1N)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    3nethra neo HD FA; 3nethra neo HD

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Resolve Fundus Camera

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Sentinel Camera

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

    Other Clearances by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

    K Number Device Name
    K242930 Natus BrainWatch System
    K233649 ALGO Pro Newborn Hearing Screener (ALGO Pro)
    K200878 Natus NeuroWorks
    K173936 Natus Photic Stimulator
    K180290 Natus Brain Monitor Amplifier
    K180421 Natus NeuroWorks
    K173690 Grass TWin
    K172711 Comet-PLUS
    K163163 XLTEK EMU40EX EEG Headbox
    K162595 Trex_HD
    Search all 12 clearances from Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) →