Skip to content

3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display

by D-View Display Technology Co., Ltd.

510(k) K151854

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK151854 Date28 Jul 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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

Overview

AI-generated summary, 23 Sep 2026

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

The device is an LCD display with 3MP and 2MP resolution variants, identified by model numbers X213C3P0E, X213G3P0E for the 3MP version and X213C2P0E, X213G2P0E for the 2MP version. It is designed for medical imaging visualization, providing high-resolution grayscale or color output suitable for diagnostic review.

The device is supplied as a non-sterile, reusable LCD display intended for use in radiology settings. It received FDA 510(k) clearance (K151854) on July 28, 2015, as substantially equivalent to a predicate device, and is authorized for marketing under product code LLZ. Storage and operational conditions should follow manufacturer guidelines, though specific environmental or safety details such as MRI compatibility are not provided in the data.

Questions

AI-generated answers, 23 Sep 2026

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

  • What is the 3MP and 2MP LCD Display used for?

    The device is designed for medical imaging visualization, providing high-resolution grayscale or color output suitable for diagnostic review in radiology settings, as stated in the device description.

  • How is the 3MP and 2MP LCD Display supplied and is it sterile or reusable?

    The device is supplied as a non-sterile, reusable LCD display intended for use in radiology settings, meaning it is not provided sterile and is designed for multiple uses following manufacturer guidelines.

  • What are the model numbers for the 3MP and 2MP versions of the LCD Display?

    The 3MP version is identified by model numbers X213C3P0E and X213G3P0E, while the 2MP version uses model numbers X213C2P0E and X213G2P0E, as specified in the device name and description.