FDA DEN 170022 QuantX

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