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DX-D Imaging Package

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

510(k) K122736 Product code MQB

Overview

The DX-D Imaging Package is a Solid State X-Ray Imager (Flat Panel/Digital Imager). This device is designed for capturing diagnostic radiographic images of human anatomy, providing high-resolution digital outputs for radiologic assessment. It is intended for use in general radiographic imaging applications, ensuring clear visualization of internal structures for clinical evaluation.

The DX-D Imaging Package is a reusable system intended for use in radiology departments. It is cleared under FDA 510(k) clearance and classified as a Class II device with product code MQB. The device is not intended for MRI environments and must be stored and maintained according to manufacturer guidelines.

DX-D Imaging Package

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 NumberK122736 Date11 Mar 2013ClearedStatusActive

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 designed for capturing diagnostic radiographic images of human anatomy. It provides high-resolution digital outputs, enabling clear visualization of internal structures for radiologic assessment in general radiographic imaging applications.

  • Is the DX-D Imaging Package reusable or single-use?

    The DX-D Imaging Package is explicitly described as a reusable system. It is intended for repeated use in radiology departments, provided it is stored and maintained according to the manufacturer’s guidelines.

  • Can this device be used in MRI environments?

    No, the DX-D Imaging Package is not intended for use in MRI environments. The manufacturer specifies that it must be stored and maintained according to their guidelines, which likely exclude exposure to MRI-compatible settings.

  • What regulatory clearance does the DX-D Imaging Package hold?

    The DX-D Imaging Package is cleared under FDA 510(k) clearance and classified as a Class II medical device with product code MQB. It was reviewed by the Radiology (RA) Advisory Committee and is substantially equivalent to a predicate device.

  • How should the DX-D Imaging Package be stored?

    The device must be stored and maintained according to the manufacturer’s guidelines to ensure proper functionality and longevity. Since it is reusable, adherence to these instructions is critical to prevent damage or degradation of performance.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K122736 24 fields · synced 22 Oct 2026