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12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)

K231026 Class II Traditional
Decision Date
2023-08-18
Sponsor / Applicant
Shenzhen Beacon Display Technology Co., Ltd.

Technical Specification

510(k) Submission ID K231026
Product Code PGY
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2050
Decision Date 2023-08-18
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) received FDA 510(k) clearance under submission number K231026, 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 2023-08-18.

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.