BEUDAMED
    Product Code: QNP FDA class 2 21 CFR 876.1520

    Gastrointesinal Lesion Software Detection System

    Gastroenterology, Urology

    The Gastrointestinal Lesion Software Detection System is a computer-assisted detection device used in conjunction with endoscopy to detect abnormal lesions in the gastrointestinal tract, using advanced software algorithms to bring attention to endoscopic images to aid in lesion detection. The device may include hardware to support interfacing with an endoscope. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 876.1520 in the Gastroenterology and Urology specialty. It carries product code QNP and is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    20
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    7
    Years Active
    5

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    Basic Information

    Product Code
    QNP
    Device Class
    FDA class 2
    Regulation Number
    876.1520
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 20 510(k) clearances via K numbers.

    K Number Device Name
    K261369 GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)
    K260724 MAGENTIQ-COLO (ME-APDS)
    K253664 SKOUT system
    K252178 MAGENTIQ-COLO (ME-APDS)
    K252586 CADDIE
    K251126 SKOUT system
    K244023 MAGENTIQ-COLO (ME-APDS)
    K241887 GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)
    K240044 CADDIE
    K241508 SKOUT® system
    K240781 SKOUT® system
    K233964 GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)
    K230751 EW10-EC02 Endoscopy Support Program
    K223473 ME-APDS™; MAGENTIQ-COLO™
    K231143 GI Genius System 100 and GI Genius System 200
    K230658 SKOUT® system
    K213686 SKOUT Software
    K211326 EndoScreener
    K211951 GI Genius
    DEN200055 GI Genius

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.