meddevicedb.com FDA Device Reference

8MP Color LCD Monitor (C81W+)

K162527 Class II Traditional
Decision Date
2016-09-30
Sponsor / Applicant
Shenzhen Beacon Display Technology Co., Ltd.

Technical Specification

510(k) Submission ID K162527
Product Code PGY
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2050
Decision Date 2016-09-30
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

8MP Color LCD Monitor (C81W+) received FDA 510(k) clearance under submission number K162527, sponsored by Shenzhen Beacon Display Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-09-30.

Classification & Regulation

This clearance is catalogued under FDA product code PGY and 21 CFR 892.2050, within the Radiology review panel as a Class II device.