# K112670: DX-D 600

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Oct 27, 2011 after 43 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K803130 (1981). 26 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103050: DX-D 300, Agfa Healthcare N.V. (2010)

## 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

## Recalls of this device
- Dec 4, 2018 · Class II · Z-0692-2019: After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane movement does not stop when the movement button is released. Instead of stopping
- Aug 15, 2018 · Class II · Z-3245-2018: A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterio
- May 2, 2016 · Class II · Z-1738-2017: One of the dent markers from the DX-D600 dropped down from the overhead rail.
- Jul 2, 2014 · Class II · Z-2175-2014: Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.

## Indications for use
The DX-D 600 system is indicated to make static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. Applications can be performed with the patient in the sitting, standing or lying position. This device is not intended for use in mammography.

Source page: https://510kreport.com/device/K112670
Methodology: https://510kreport.com/methodology