# K183275: DR 800 with Tomosynthesis

- Pathway: 510(k) (Traditional)
- Applicant: Agfa N.V.
- Decided: Feb 1, 2019 after 70 days
- Product code: IZF (System, X-Ray, Tomographic)
- Device class: 2
- Regulation: 21 CFR 892.1740
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K862120 (1986). 10 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132261: Discovery XR656 with Volumerad (Digital Tomosynthesis), Ge Medical Systems, LLC (2013) Summary page 6.
- K180589: DR 800 with MUSICA Dynamic, Agfa Healthcare N.V. (2018) Summary page 6.

## Most influential descendants
- K193262: DR 600 with Tomosynthesis (2020), 4 descendants of its own
- K222934: Nanox.ARC (2023), 3 descendants of its own
- K242395: Nanox.ARC (2024), 2 descendants of its own
- K250850: Nanox.ARC X (2025), 1 descendant of its own
- K221949: Ortho Device, ADAPTIX 3D Orthopedic Imaging System (2023), 1 descendant of its own

## Recalls of this device
- Nov 18, 2025 · Class II · Z-0923-2026: 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
- Jul 29, 2024 · Class II · Z-2738-2024: Potential for the front lever chain of the DR 800 table to fail.
- Feb 10, 2020 · Class II · Z-1502-2020: Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.

## Indications for use
The DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: • Positioning fluoroscopy procedures • Gastro-intestinal examinations • Urogenital tract examinations • Angiography It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-Ray systems. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications.

Source page: https://510kreport.com/device/K183275
Methodology: https://510kreport.com/methodology