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DX-D Imaging Package

by Agfa Healthcare N.V. United States 510(k)

510(k) K142184 Product code MQB

Overview

The DX-D Imaging Package is a Solid State X-Ray Imager (Flat Panel/Digital Imager) used in radiology. It is a Class II medical device with product code MQB and regulation number 892.1680.

The device received FDA 510(k) clearance under K142184 on October 16, 2014, following a traditional review. It was determined to be substantially equivalent to a predicate device. The manufacturer is Agfa Healthcare N.V., located in Greenville, SC, US.

Summary written by AI from registry data, 1 Oct 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 NumberK142184 Date16 Oct 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 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
MQB
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Agfa Healthcare N.V.

See all devices from Agfa Healthcare N.V. →

Questions

  • What is the DX-D Imaging Package used for?

    The DX-D Imaging Package is a Solid State X-Ray Imager (Flat Panel/Digital Imager) used in radiology to capture digital radiographic images, as indicated by its device name and product code MQB under regulation 892.1680.

  • Who manufactures the DX-D Imaging Package and where are they located?

    The DX-D Imaging Package is manufactured by Agfa Healthcare N.V., located at 10 S. Academy St., Greenville, SC 29601, United States, as specified in the manufacturer and address fields.

  • What regulatory pathway was used for the DX-D Imaging Package and when was it cleared?

    The DX-D Imaging Package received FDA 510(k) clearance under K142184 on October 16, 2014, following a traditional review process, after being determined substantially equivalent to a predicate device.

  • What is the device classification and product code for the DX-D Imaging Package?

    The DX-D Imaging Package is a Class II medical device with product code MQB, corresponding to the regulation number 892.1680 for Solid State X-Ray Imagers (Flat Panel/Digital Imager).

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K142184 24 fields · synced 22 Oct 2026