Skip to content

5MP Grayscale LCD Display

by Shenzhen Beacon Display Technology Co., Ltd.

510(k) K132610

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132610↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK132610 Date4 Sep 2013ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132610 decided 4 Sep 2013 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
LLZ
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a 5MP Grayscale LCD Display, classified under the product code LLZ in the FDA’s nomenclature. It is a high-resolution liquid crystal display designed for medical imaging applications, providing clear visual output for diagnostic radiology workflows.

The 5MP Grayscale LCD Display is intended for use in radiology settings, where its 5-megapixel resolution and grayscale imaging capabilities support accurate interpretation of medical images. Supplied as a standalone unit, it requires no sterilization and is intended for reusable clinical environments. The device holds FDA 510(k) clearance under the Radiology Advisory Committee and complies with MDR requirements.

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Shenzhen Beacon Display Technology Co., Ltd.

See all devices from Shenzhen Beacon Display Technology Co., Ltd. →