Dr 400

510(k) Number

K141192 ↗

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. →

• Is the DR 400 designed for single-use or can it be reused in clinical settings?

  The DR 400 is explicitly described as a reusable medical instrument, suitable for repeated use in radiology settings. Since it is classified as a reusable device, proper cleaning, disinfection, and maintenance protocols must be followed to ensure safety and performance between uses.

• What types of radiographic procedures is the DR 400 intended to support, and how does its flat-panel technology benefit diagnostic clarity?

  The DR 400 is a Solid State X-Ray Imager (Flat Panel/Digital Imager) designed for capturing high-resolution radiographic images in radiology settings. Its flat-panel technology converts X-ray exposure into digital signals, enabling real-time imaging and significantly enhancing diagnostic clarity by providing detailed, immediate visualizations for procedures like general radiography, orthopedics, and other radiographic evaluations.

• How is the DR 400 integrated into existing imaging workflows, and are there any compatibility considerations mentioned?

  The DR 400 is compatible with standard radiographic imaging workflows, meaning it can be seamlessly integrated into existing systems without requiring major infrastructure changes. While the device is designed for general radiology use, its integration specifics—such as connectivity, software compatibility, or system requirements—are not detailed in the provided data. Users should verify compatibility with their specific imaging systems before deployment.

• What regulatory pathways has the DR 400 followed, and what does this mean for its use in clinical environments?

  The DR 400 has received FDA 510K clearance and MDR authorization, confirming its compliance with U.S. and EU regulatory standards. This means the device meets the necessary safety and performance requirements for use in clinical radiology settings, though specific clinical indications or limitations are not outlined in the provided data. Always follow manufacturer guidelines and local regulations for proper use.

• Are there any specific storage or handling requirements mentioned for the DR 400?

  The provided data does not explicitly detail storage or handling requirements for the DR 400, such as environmental conditions (e.g., temperature, humidity) or protective measures. Since it is a reusable device, proper cleaning and maintenance protocols will be critical to ensure longevity and performance. Users should refer to the manufacturer’s instructions for detailed guidance on storage and handling.