FDA DEN 170022 QuantX

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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 C FR 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: 2118Fully redacted pages: 1855Content pages: 263 Show more