# K212145: DR 800 with DSA, DR 800

- Pathway: 510(k) (Traditional)
- Applicant: Agfa N.V.
- Decided: Aug 31, 2021 after 53 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K862120 (1986). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190373: SonialVision G4, Shimadzu Corporation (2019) Summary page 4.
- K183275: DR 800 with Tomosynthesis, Agfa N.V. (2019) Summary page 4.

## Indications for use
The DR 800 with DSA 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 • Digital Subtraction Angiography It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for projection 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. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Not intended for cardiovascular and cerebrovascular contrast studies. Not intended for mammography applications.

Source page: https://510kreport.com/device/K212145
Methodology: https://510kreport.com/methodology