Cleared Traditional

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 · Shenzhen Beacon Display Technology Co., Ltd. · Radiology

Aug 2023

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K231026 is an FDA 510(k) clearance for the 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), a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Shenzhen Beacon Display Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 18, 2023, 129 days after receiving the submission on April 11, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K231026 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2023
Decision Date	August 18, 2023
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	PGY — Display, Diagnostic Radiology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2050
Definition	The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners.