# K180589: DR 800 with MUSICA Dynamic

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Apr 5, 2018 after 30 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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: 1 generation back to K140380 (2014). 1 ancestor in all.
9 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140380: Opera Swing, General Medical Merate S.P.A (2014) Summary page 4.

## Most influential descendants
- K183275: DR 800 with Tomosynthesis (2019), 8 descendants of its own
- 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

## Recalls of this device
- Jul 29, 2024 · Class II · Z-2738-2024: Potential for the front lever chain of the DR 800 table to fail.
- Apr 6, 2020 · Class II · Z-2202-2020: Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
- Jun 27, 2019 · Class II · Z-2056-2019: The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.

## 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. The DR 800 is not intended for mammography applications.

Source page: https://510kreport.com/device/K180589
Methodology: https://510kreport.com/methodology