DR 800 with Tomosynthesis

• • Ongoing Z-0923-2026 FDA Class II ·initiated 18 Nov 2025

  It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.

• • Ongoing Z-2738-2024 FDA Class II ·initiated 29 Jul 2024 ·via K183275, on the same 510(k)

  Potential for the front lever chain of the DR 800 table to fail.

• • Terminated Z-1502-2020 FDA Class II ·initiated 10 Feb 2020

  Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K183275 ↗

FDA Product Code

IZF

Device Class

Class II

Regulation

21 CFR Part 892.1740

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• DR 800 with DSA, DR 800

  Class II

  FDA 510(k) K212145 Active Cleared 31 Aug 2021

• DX-D Imaging Package with XD Detectors

  Class II

  FDA 510(k) K211790 Active Cleared 30 Jul 2021

• DR 600 with Tomosynthesis

  Class II

  CE/MDR FDA 510(k) K193262 Active Cleared 9 Mar 2020

• What types of imaging studies is the DR 800 with Tomosynthesis designed to improve, and how does it differ from traditional 2D X-ray systems?

  The DR 800 with Tomosynthesis is specifically designed to enhance diagnostic imaging in challenging scenarios like breast and musculoskeletal examinations. Unlike traditional 2D X-ray systems, it combines digital radiography with tomosynthesis technology to create high-resolution, layered images. This reduces artifacts and improves spatial resolution, giving radiologists clearer, more detailed anatomical visualization for better diagnostic confidence.

• Is the DR 800 with Tomosynthesis a single-use or reusable device, and what does this mean for maintenance and sterility?

  The DR 800 with Tomosynthesis is a reusable device, meaning it is not intended for single-use applications. Since it is not sterile by design, maintenance and cleaning must follow the manufacturer’s guidelines to ensure optimal performance and image quality. Sterility is not a requirement for this system, as it operates in controlled clinical settings.

• What regulatory pathways has the DR 800 with Tomosynthesis followed, and which governing bodies have approved its use?

  The DR 800 with Tomosynthesis has undergone FDA clearance through a 510(k) submission (K183275) and complies with EU Medical Device Regulation (MDR). It is classified as a Class II medical imaging system, adhering to both U.S. and EU regulatory standards for digital tomographic imaging systems.

• What special considerations should be taken into account when storing or maintaining the DR 800 with Tomosynthesis?

  The DR 800 with Tomosynthesis requires adherence to the manufacturer’s storage and maintenance guidelines to preserve performance and image quality. Since it is a reusable system, proper cleaning and upkeep are essential. There are no noted MRI safety restrictions, but standard radiology department protocols should be followed to ensure optimal functionality and longevity of the device.

• Does the DR 800 with Tomosynthesis support additional imaging modalities beyond tomosynthesis, and if so, what are they?

  Yes, the DR 800 with Tomosynthesis is designed as a fully integrated digital imaging solution that supports standard radiography and fluoroscopy, in addition to its advanced tomosynthesis capabilities. This versatility allows radiology departments to use it for a range of diagnostic applications beyond just layered imaging.