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

    SPY Portable Handheld Imaging (SPY-PHI) System

    K Number: K200737 · Decision May 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    60
    Applicant Total
    6
    Review Days
    59

    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
    SPY Portable Handheld Imaging (SPY-PHI) System
    K Number
    K200737
    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
    March 23, 2020
    Decision Date
    May 21, 2020
    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

    Similar 510(k) Clearances

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

    SmartSurgN Visualization System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    KARL STORZ ICG Imaging System with RUBINA® Lens

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    IMAGE1 (TC400US); X-to-4U Adapter (TC040)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    L12 LED Light Source with AIM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    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
    K192174 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