# K192440: FDR SE Lite

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Nov 1, 2019 after 56 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: 11 generations back to K981556 (1998). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142003: FDR D-Evo II Flat Panel Detector System, Fujifilm Medical System U.S.A., Inc. (2014) Summary page 4.

## Indications for use
The FDR SE Lite flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The FDR SE Lite is not intended for mammography, fluoroscopy, tomography, and angiography applications, as well as pediatric and neonatal exams.

Source page: https://510kreport.com/device/K192440
Methodology: https://510kreport.com/methodology