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

    SPY Portable Handheld Imaging (SPY-PHI) System

    K Number: K192174 · Decision Nov 15, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    60
    Applicant Total
    6
    Review Days
    95

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    Basic Information

    Device Name
    SPY Portable Handheld Imaging (SPY-PHI) System
    K Number
    K192174
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novadaq Technologies Ulc. (Now A Part of Stryker)
    Date Received
    August 12, 2019
    Decision Date
    November 15, 2019
    Product Code
    OWN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OWN Confocal Optical Imaging

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    Other Clearances by Novadaq Technologies Ulc. (Now A Part of Stryker)

    K Number Device Name
    K202244 SPY-PHI System with SPY-PHI Fluorescence Assessment Software
    K200737 SPY Portable Handheld Imaging (SPY-PHI) System
    K190729 SPY Portable Handheld Imaging (SPY-PHI) System
    K182907 SPY Elite Intraoperative Perfusion Assessment System
    K182606 PINPOINT Endoscopic Fluorescence Imaging System