meddevicedb.com FDA Device Reference

QuantX

DEN170022 Class II Direct
Decision Date
2017-07-19
Sponsor / Applicant
Quantitative Insights, Inc.

Technical Specification

510(k) Submission ID DEN170022
Product Code POK
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2060
Decision Date 2017-07-19
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

QuantX received FDA 510(k) clearance under submission number DEN170022, sponsored by Quantitative Insights, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2017-07-19.

Classification & Regulation

This clearance is catalogued under FDA product code POK and 21 CFR 892.2060, within the Radiology review panel as a Class II device.