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510(k) K243031

LCD Monitors C310S, G310S, C316S, G316S, C616W by Shenzhen Beacon Display Technology Co., Ltd. — Product Code PGY

K243031 is an FDA 510(k) premarket notification submitted by Shenzhen Beacon Display Technology Co., Ltd. for the device "LCD Monitors C310S, G310S, C316S, G316S, C616W". The FDA issued a decision of Substantially Equivalent on October 25, 2024. 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
October 25, 2024
Date Received
September 27, 2024
Clearance Type
Special
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.

Other clearances by Shenzhen Beacon Display Technology Co., Ltd.

  • K252780 — LCD Monitor (CL1902A, CL2103F) (December 19, 2025)
  • K253242 — LCD Monitor (C1216W, C822W, C821W) (October 29, 2025)
  • K233119 — 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T (December 28, 2024)
  • K240310 — LCD Monitors C310S, G310S, C316S, G316S, C616W (March 29, 2024)
  • K233897 — 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, (February 6, 2024)
  • K231026 — 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the diff (August 18, 2023)
  • K202374 — 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+ (October 19, 2020)
  • K201211 — 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ (September 3, 2020)
  • K201599 — 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ (July 2, 2020)
  • K200864 — 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ (May 19, 2020)

Other clearances for product code PGY

  • K261213 — Medical Monitor (40HT513D) (June 12, 2026)
  • K252780 — LCD Monitor (CL1902A, CL2103F) (December 19, 2025)
  • K253242 — LCD Monitor (C1216W, C822W, C821W) (October 29, 2025)
  • K252030 — RadiForce GX570; RadiForce GX570-AR (August 28, 2025)
  • K243221 — RadiForce RX570; RadiForce RX570-AR (November 27, 2024)
  • K242008 — Coronis OneLook (August 2, 2024)
  • K241105 — 3MP Color LCD Monitor (CL-S301) (August 1, 2024)
  • K241441 — RadiForce RX670; RadiForce RX670-AR (July 16, 2024)
  • K241499 — 21.3” 5MP Color LCD Display UMD5-21B01 (June 13, 2024)
  • K233336 — 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) (May 21, 2024)

FDA data resources