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15-INCH (38CM) Color LCD Monitor CDL1566A

by Totoku Electric Co., Ltd.

510(k) K060961

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 NumberK060961 Date1 May 2006ClearedStatusActive

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  • Withdrawn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 a 15-inch (38cm) color LCD monitor, model CDL1566A, as specified in the device name and specifications. It is a medical device used for displaying visual information, consistent with its classification under the Radiology advisory committee.

The device was cleared via the FDA 510(k) pathway under K060961, with a traditional clearance type and a substantially equivalent decision. It is manufactured by Totoku Electric Co., Ltd. and is intended for use in radiological settings as indicated by the advisory committee classification.

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See all devices from Totoku Electric Co., Ltd. →

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 15-INCH (38CM) COLOR LCD MONITOR CDL1566A used for?

    The device is a medical display used for showing visual information in radiological settings, as indicated by its classification under the Radiology advisory committee, and is intended for clinical viewing of medical images.

  • How was the CDL1566A monitor cleared for market release?

    The CDL1566A received FDA 510(k) clearance under submission K060961 on May 1, 2006, through a traditional review process with a substantially equivalent determination, meaning it was found to be as safe and effective as a legally marketed predicate device.

  • Who manufactures the CDL1566A monitor and where is it made?

    The CDL1566A is manufactured by Totoku Electric Co., Ltd., with the manufacturer's address listed as 300 Oya, Ueda, Japan, postal code 386-0192, and the contact person is Mikio Hasegawa.