# K103050: DX-D 300

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Oct 29, 2010 after 14 days
- Product code: KPR (System, X-Ray, Stationary)
- 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: 6 generations back to K803130 (1981). 25 ancestors in all.
8 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)
- K092669: DX-D Imaging Package, Agfa Healthcare N.V. (2009) Summary page 1.
- K062335: Sedecal X Plus LP Plus, Sedecal., Sa. (2006) Summary page 1.

## Most influential descendants
- K112670: DX-D 600 (2011), 7 descendants of its own
- 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

## Indications for use
Agfa's DX-D 300 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. Agfa's DX-D 300 is not indicated for use in mammography.

Source page: https://510kreport.com/device/K103050
Methodology: https://510kreport.com/methodology