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21.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A)

by Totoku Electric Co., Ltd.

510(k) K081056

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 NumberK081056 Date4 Jun 2008ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The 21.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A) is a medical imaging display device that supports DVI video signal and provides UXGA (1536 x 2048) resolution for both landscape and portrait orientations. It is designed for displaying and viewing medical images for diagnosis by trained medical professionals.

This monitor is manufactured by Totoku Electric Co., Ltd. and is a Class II device cleared under FDA 510K with K-number K081056. It is intended for use in radiology settings and is part of the Picture Archiving and Communication System (PACS) category. The device is supplied as a standalone monitor and requires appropriate storage conditions to maintain its performance.

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