Skip to content

DX-D Imaging Package

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

510(k) K172784 Product code MQB

Overview

The DX-D Imaging Package is a Solid State X-Ray Imager (Flat Panel/Digital Imager) designed for general projection radiographic applications. It captures diagnostic quality radiographic images of human anatomy for adult, pediatric and neonatal examinations.

The device may be used wherever conventional screen-film systems, CR or DR systems may be used. It is supplied by Agfa Healthcare N.V. and has FDA 510(k) clearance with the product code MQB. The device is Class II with special controls.

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 NumberK172784 Date13 Oct 2017ClearedStatusActive

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 designed for general projection radiographic applications. It captures diagnostic quality radiographic images of human anatomy for adult, pediatric and neonatal examinations, and can be used wherever conventional screen-film systems, CR or DR systems may be used.

  • How is the DX-D Imaging Package supplied?

    The DX-D Imaging Package is supplied by Agfa Healthcare N.V. It is a Class II device with special controls and has FDA 510(k) clearance with the product code MQB. The device is designed for general projection radiographic applications in various medical settings.

  • What are the regulatory approvals for the DX-D Imaging Package?

    The DX-D Imaging Package has FDA 510(k) clearance with the product code MQB. It is classified as a Class II device with special controls. The device was reviewed by the Radiology Advisory Committee and received a decision of 'Substantially Equivalent' on October 13, 2017.

  • Can the DX-D Imaging Package be used for different patient sizes?

    Yes, the DX-D Imaging Package is designed to capture diagnostic quality radiographic images for adult, pediatric and neonatal examinations. It can be used wherever conventional screen-film systems, CR or DR systems may be used, making it versatile for various patient sizes and examination types.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K172784 24 fields · synced 22 Oct 2026