# K141743: Fusion Digital Diagnostic X-Ray Upgrade Kit

- Pathway: 510(k) (Traditional)
- Applicant: Radiology Solutions, LLC
- Decided: Oct 3, 2014 after 95 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 K981556 (1998). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132294: Galaxy and Galaxy+Plus Digital Radiography Systems, Radiology Solutions, LLC (2013) Summary page 4.

## Indications for use
This flat panel digital imaging system is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for use by qualified medical personnel. (Not for mammography)

Source page: https://510kreport.com/device/K141743
Methodology: https://510kreport.com/methodology