# K141192: DR 400

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Jun 6, 2014 after 29 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K803130 (1981). 25 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122736: DX-D Imaging Package, Agfa Healthcare N.V. (2013) Summary page 1.
- K012546: Optima Urs Universal Radiographic System, Sedecal USA, Inc. (2001) Summary page 1.

## Most influential descendants
- K152639: DR 600 (2015), 6 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

## Indications for use
The DR 400 system is a GenRad X-ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult and pediatric patients. Applications can be performed with the patient in the sitting, standing or lying Position. Agfa's DR 400 is not indicated for use in mammography.

Source page: https://510kreport.com/device/K141192
Methodology: https://510kreport.com/methodology