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Mdmc-12133

by Barco N.V. United States 510(k)

510(k) K141428 Product code PGY

Overview

The Coronis Uniti MDMC-12133 is a 12MP diagnostic display system designed for PACS and breast imaging. It features calibrated color and grayscale representation with 2D and 3D capabilities. This monitor is specifically engineered for diagnostic radiology applications.

The device is supplied as a single unit and is intended for diagnostic use in radiology settings. It is not specified as single-use or reusable, and no MRI safety information is provided. The device has received FDA 510(k) clearance with product code PGY and is classified as a Class II medical device.

Summary written by AI from registry data, 25 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK141428 Date27 Jun 2014ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

510(k) · synced 6 Oct 2026

510(k) Number
FDA Product Code
PGY
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Coronis Uniti MDMC-12133 used for?

    The Coronis Uniti MDMC-12133 is a 12MP diagnostic display system specifically designed for PACS and breast imaging applications in radiology settings. It features calibrated color and grayscale representation with both 2D and 3D capabilities to support diagnostic imaging needs.

  • How is the Coronis Uniti MDMC-12133 supplied?

    The device is supplied as a single unit intended for diagnostic use in radiology settings. The product does not specify whether it is single-use or reusable, and no MRI safety information is provided in the available documentation.

  • What is the regulatory status of the Coronis Uniti MDMC-12133?

    The Coronis Uniti MDMC-12133 has received FDA 510(k) clearance with product code PGY and is classified as a Class II medical device. It was determined to be substantially equivalent to predicate devices through the traditional clearance process.

  • What are the key specifications of the Coronis Uniti MDMC-12133?

    This diagnostic display system offers 12MP resolution with calibrated color and grayscale representation. It is engineered specifically for diagnostic radiology applications and supports both 2D and 3D imaging capabilities for use in PACS and breast imaging workflows.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K141428 24 fields · synced 6 Oct 2026