# K122454: Fujifilm Dual Energy Subtraction (Des) Software Option

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Nov 20, 2012 after 99 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: 5 generations back to K862120 (1986). 7 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952862: Fuji Computed Radiography System FCR9501ES.FCR, Fujifilm Medical System U.S.A., Inc. (1995) Summary page 3.
- K013481: Dual Energy and Tissue Equalization Software Option, GE Medical Systems (2001) Summary page 3.

## Most influential descendants
- K152244: RADspeed Pro (2016), 3 descendants of its own
- K173517: RADspeed fit (2018), 1 descendant of its own
- K152294: FDR Visionary Suite (2016), 1 descendant of its own
- K233719: FDR Visionary Suite (2024), 0 descendants of its own
- K233722: RADspeed Pro (2024), 0 descendants of its own

## Indications for use
Fujifilm’s FDR Dual Energy Subtraction (DES) Option may be used with Fuijifilm's DR X-ray Systems and is intended to be used by a qualified/trained doctor or technologist for acquiring dual energy subtraction images of human anatomy. DES is intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying / overlying anatomical structures. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K122454
Methodology: https://510kreport.com/methodology