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DR 600 with Tomosynthesis

by Agfa N.V. Belgium EUDAMED510(k)

510(k) K193262

Product code IZF

Overview

The DR 600 with Tomosynthesis is a digital X-ray system designed for tomographic imaging, classified as an X-Ray, Tomographic System. It combines conventional radiography with tomosynthesis capabilities to provide detailed cross-sectional images of anatomical structures, enhancing diagnostic accuracy for radiology applications.

This device is supplied as a ceiling-mounted system and is intended for use in radiology settings. It is intended for single-use components where applicable, though the primary imaging unit is reusable. The system operates under FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for medical imaging devices. No specific MRI safety classification or sterility requirements are stated in the provided data.

Summary written by AI from registry data, 18 Sep 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 510(k) Substantially Equivalent · Traditional NumberK193262 Date9 Mar 2020ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
IZF
Device Class
Class II
Regulation
21 CFR Part 892.1740
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Agfa N.V.

Questions

  • What types of imaging does the DR 600 with Tomosynthesis support, and how does it improve diagnostic accuracy compared to traditional X-ray systems?

    The DR 600 with Tomosynthesis combines conventional radiography with tomosynthesis, enabling detailed cross-sectional imaging of anatomical structures. Unlike traditional X-ray systems, which provide flat, two-dimensional images, this system creates multiple thin slices to reduce overlap and improve visualization of structures like breast tissue, bones, or soft tissues. This enhances diagnostic accuracy by making subtle details more discernible, particularly useful in radiology applications.

  • Is the DR 600 with Tomosynthesis designed for ceiling mounting, and what does this mean for installation flexibility?

    Yes, the DR 600 with Tomosynthesis is supplied as a ceiling-mounted system, which allows for efficient use of floor space in radiology settings. Ceiling mounting provides stability and reduces clutter in the room, while also offering flexibility in positioning the device to accommodate different patient workflows and room layouts. This design is particularly advantageous in busy clinical environments where space optimization is important.

  • Are any components of the DR 600 with Tomosynthesis intended for single-use, and how does this affect maintenance and cost?

    The DR 600 with Tomosynthesis includes single-use components where applicable, which helps minimize infection control risks and streamline maintenance. Single-use parts reduce the need for sterilization and cleaning between patients, lowering operational costs associated with reprocessing. However, the primary imaging unit itself is reusable, ensuring long-term durability and cost-effectiveness for the facility.

  • What regulatory pathways has the DR 600 with Tomosynthesis followed, and what does this mean for compliance in different markets?

    The device has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming compliance with U.S. and EU regulatory standards. This dual authorization ensures that the system meets stringent safety, performance, and quality requirements in both markets. For buyers, this means the device adheres to globally recognized regulatory frameworks, reducing compliance risks and facilitating smoother integration into clinical workflows.

  • How does the DR 600 with Tomosynthesis support radiology workflows, and what specialties would benefit most from its capabilities?

    The DR 600 with Tomosynthesis is specifically designed for radiology settings, offering advanced imaging that supports detailed diagnostic evaluations. Specialties like mammography, musculoskeletal radiology, and general radiology would benefit most from its cross-sectional imaging capabilities, as it enhances the detection of abnormalities such as calcifications, fractures, or soft tissue lesions. Its versatility makes it a valuable tool for improving diagnostic confidence and patient outcomes.

Properties & raw data

Show properties, registry sources and raw records

Sources (2)

  • FDA 510(k) K193262 24 fields · synced 22 Oct 2026
  • EUDAMED 1 fields · synced 19 May 2026