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20.8-INCH (53CM) Color LCD Monitor CDL2119A (CCL352I2)

by Totoku Electric Co., Ltd.

510(k) K072065

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 NumberK072065 Date14 Aug 2007ClearedStatusActive

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  • Withdrawn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, 25 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 CDL2119A (CCL352I2) is a 20.8-inch, 3-megapixel color LCD monitor designed for clinical diagnostic imaging. It accepts DVI video signals and provides UXGA (1536 x 2048) resolution, supporting both landscape and portrait orientations.

This monitor is intended for displaying and viewing medical images for diagnosis by trained medical practitioners. It is supplied by Totoku Electric Co., Ltd. and has FDA 510(k) clearance with K number K072065. The device is classified under product code LLZ as a System, Image Processing, Radiological device.

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Questions

AI-generated answers, 25 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 resolution and video input does the CDL2119A monitor provide for diagnostic imaging?

    The monitor supports UXGA resolution of 1536 × 2048 pixels and accepts DVI video signals, allowing high‑detail image display in both landscape and portrait orientations, which is essential for accurate medical interpretation.

  • Is the CDL2119A intended for single‑use or repeated clinical use, and how is it supplied?

    It is a reusable clinical display supplied by Totoku Electric Co., Ltd. as a finished system; users can install it in imaging workstations and employ it repeatedly for patient examinations, provided standard cleaning and maintenance procedures are followed.

  • What regulatory clearance does the CDL2119A have, and what does that imply for clinicians?

    The device has FDA 510(k) clearance (K072065) under product code LLZ, indicating it is substantially equivalent to a legally marketed predicate. Clinicians can rely on its compliance with applicable safety and performance standards for radiological image viewing.

  • Can the monitor be oriented both horizontally and vertically, and why is that useful?

    Yes, the monitor supports both landscape and portrait orientations. This flexibility lets clinicians adjust the display to match the aspect ratio of various imaging modalities, such as radiographs or pathology slides, improving workflow and image interpretation.