# K152639: DR 600

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Dec 11, 2015 after 87 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: 8 generations back to K803130 (1981). 29 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112670: DX-D 600, Agfa Healthcare N.V. (2011) Summary page 4.
- K141192: DR 400, Agfa Healthcare N.V. (2014) Summary page 4.

## 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
- K252649: TAP2D (2026), 0 descendants of its own

## Indications for use
The DR 600 is a GenRad X-ray imaging system used in hospitals, clinics and medical practices by radiographers. radiologists and physicists to make, process and view static X-ray radiographic images of the skeleton (including skull, spmnal column and extremities), chest, abdomen and other body parts on adults and pediatric patients. Applications can be performed with the patient in sitting, standing or lying position. The DR 600 is not intended for use in Mammography applications.

Source page: https://510kreport.com/device/K152639
Methodology: https://510kreport.com/methodology