meddevicedb.com FDA Device Reference

CSX-30 Flat Panel Detector

K162909 Class II Traditional
Decision Date
2017-01-27
Sponsor / Applicant
Canon, Inc. – Medical Equipment Group

Technical Specification

510(k) Submission ID K162909
Product Code MQB
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1680
Decision Date 2017-01-27
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

CSX-30 Flat Panel Detector received FDA 510(k) clearance under submission number K162909, sponsored by Canon, Inc. – Medical Equipment Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2017-01-27.

Classification & Regulation

This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.