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Unisight Mammography Viewer, Model 4.0

by Electronic Business Machine Co., Ltd. (Ebm)

510(k) K062743

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 NumberK062743 Date31 Oct 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  • Withdrawn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, 5 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 Unisight Mammography Viewer, Model 4.0, is a Class II X-ray system. It functions as a radiological image processing system, specifically for mammography.

This device is used in radiology and was cleared under K-number K062743 in 2006. It is classified under product code LLZ, which includes advanced image processing and PACS-adjacent software, and is subject to special controls.

Other devices from Electronic Business Machine Co., Ltd. (Ebm)

Questions

AI-generated answers, 5 Oct 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 Unisight Mammography Viewer, Model 4.0, used for?

    The Unisight Mammography Viewer, Model 4.0, is a Class II X-ray system designed for radiological image processing, specifically for mammography images.

  • What is the product code classification for this device?

    This device is classified under product code LLZ, which encompasses advanced image processing and PACS-adjacent software, and is subject to special controls.

  • When was the Unisight Mammography Viewer, Model 4.0, cleared?

    The Unisight Mammography Viewer, Model 4.0, was cleared under K-number K062743 in 2006.