DX-D Imaging Package

510(k) Number

K141602 ↗

FDA Product Code

MQB

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• DX-D Imaging Package

  Class II

  FDA 510(k) K172784 Active Cleared 13 Oct 2017

• DR 800 with MUSICA Dynamic Open recall

  Class II

  FDA 510(k) K180589 Active Cleared 5 Apr 2018

• ICIS View

  Class II

  FDA 510(k) K143397 Active Cleared 1 Jun 2015

• IMPAX Agility

  Class II

  FDA 510(k) K142316 Active Cleared 6 Jan 2015

• Agfa Computed Radiography Systems with Dx-G Digitizers

  Class II

  FDA 510(k) K092238 Active Cleared 11 Aug 2009

• IMPAX Volume Viewing 4.0

  Class II

  FDA 510(k) K161061 Active Cleared 22 Jun 2016

See all devices from Agfa Healthcare N.V. →

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

  The DX-D Imaging Package is a solid-state X-ray imager designed specifically for capturing diagnostic-quality radiographic images of human anatomy. As a digital flat panel detector, it converts X-ray exposure into electronic signals, enabling real-time high-resolution imaging in general projection radiography. This makes it ideal for radiology settings where precise and immediate visualization of internal structures is required.

• How is the DX-D Imaging Package supplied, and what models are available?

  The DX-D Imaging Package is supplied as a standalone imaging solution, intended for integration into radiology workflows. It includes multiple detector models, each with distinct technical specifications to ensure compatibility with various radiographic systems. Notable model references include 3009717300, 3015223550, and others, allowing flexibility for different clinical needs and system configurations.

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

  The DX-D Imaging Package does not have a designated sterility classification or single-use designation. Its usage depends on facility protocols and the specific detector type. Facilities must follow their own cleaning, disinfection, and reuse procedures to ensure safety and compliance with regulatory standards.

• What regulatory pathway was followed for FDA clearance?

  The DX-D Imaging Package received FDA 510(k) clearance through the Traditional pathway, demonstrating substantial equivalence to a predicate device. It is classified as a Class 2 medical device under FDA regulations (product code MQB), which reflects its moderate risk level and the need for specific manufacturing controls.

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

  While the provided data does not specify storage conditions explicitly, proper handling and storage of digital radiographic detectors like the DX-D Imaging Package generally involve protecting them from physical damage, extreme temperatures, and environmental contaminants. Facilities should follow manufacturer guidelines and institutional protocols to maintain detector performance and longevity, ensuring they are stored in a clean, dry environment when not in use.