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FDA 510(k)

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)

K-Number: K231026 · 2023-08-18

ApplicantShenzhen Beacon Display Technology Co., Ltd.
Decision Date2023-08-18
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device 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) is a medical device manufactured by Shenzhen Beacon Display Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-18 under approval number K231026. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is 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)?

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) is a medical device that received FDA 510(k) clearance on 2023-08-18. It is manufactured by Shenzhen Beacon Display Technology Co., Ltd.. The 510(k) number is K231026.

When was 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) approved by the FDA?

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 on 2023-08-18, under approval number K231026.

What company makes 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)?

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) is manufactured by Shenzhen Beacon Display Technology Co., Ltd..

What is the FDA product code for 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 product code for 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) is PGY.

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Related PubMed Literature

PMID: 42086270 Abdominopelvic computed tomography during pregnancy and the risk of congenital malformations: protocol for a nationwide population-based cohort study in South Korea. BMJ open (2026) PMID: 41638310 Lower Extremity Complications in Adults With Type 2 Diabetes Treated With Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Cotransporter 2 Inhibitors, Dipeptidyl Peptidase-4 Inhibitors, and Sulfonylureas: An Emulated Target Trial. Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists (2026) PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025) PMID: 40978510 Federated learning: a privacy-preserving approach to data-centric regulatory cooperation. Frontiers in drug safety and regulation (2025)

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

K1625278MP Color LCD Monitor (C81W+) K1728152MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) K1822916MP Color LCD Monitor (C61W+) K2023744MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+ K2012113MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ K2015992MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+

View all 14 devices →

Related Devices (Code: PGY)

K1633356MP Color LCD Monitor, RadiForce RX660, RX660-AREizo Corporation K1625278MP Color LCD Monitor (C81W+)Shenzhen Beacon Display Technology Co., Ltd. K1624975MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation K1618952MP Color LCD Monitor CCL214 (CL21214)Jvckenwood Corporation K162196Dell UP3216Q with QUBYX PerfectLum bundleQubyx Software Technologies, Inc. K161229Mammo Tomosynthesis (MDMG-5221)Barco N.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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