# K170451: FDX Console (DR-ID300CL) Software

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Mar 16, 2017 after 29 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K981556 (1998). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153464: FDR D-EVO flat Panel Detector System, Fujifilm Medical Systems U.S.A, Inc. (2016) Summary page 4.
- K041990: Fuji Medical CR Console, Model Flash Iip, Fujifilm Medical System U.S.A., Inc. (2004) Summary page 4.

## Indications for use
The FDX Console is a workstation intended to associate digital (CR and/or DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. The FDX Console is not for use in Mammography.

Source page: https://510kreport.com/device/K170451
Methodology: https://510kreport.com/methodology