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    FDA DEN 170022 QuantX

    FDA DEN 170022 QuantX

    $625.88 USD
    $625.88 USD
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    DEN Number: DEN170022 
    Device Name: QuantX 
    Applicant / Sponsor: Quantitative Insights, Inc., Chicago, IL 
    Decision Status: Granted (De Novo) on July 19, 2017. 
    Regulation Number: 21 CFR 892.2060 
    Product Code: POK 
    Final Classification: Class II (special controls) device type: Radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer.

    Total pages: 2118
    Fully redacted pages: 1855
    Content pages: 263
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