510(k) K231026

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) by Shenzhen Beacon Display Technology Co., Ltd. — Product Code PGY

K231026 is an FDA 510(k) premarket notification submitted by Shenzhen Beacon Display Technology Co., Ltd. for the device "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)". The FDA issued a decision of Substantially Equivalent on August 18, 2023. The device falls under product code PGY (Display, Diagnostic Radiology), a Class II device regulated under 21 CFR 892.2050. Shenzhen Beacon Display Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2023
Date Received
April 11, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Diagnostic Radiology
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.