# K013481: Dual Energy and Tissue Equalization Software Option

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Nov 2, 2001 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: 4 generations back to K862120 (1986). 5 ancestors in all.
45 later devices descend from it; 3 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012389: Revolution XR/D Digital Radiographic Imaging System, Ge Medical Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K092363: Softview, Model 2.01 (2010), 34 descendants of its own
- K123526: Clearread +Confirm (2012), 25 descendants of its own
- K162278: Digital Diagnostic Mobile X-ray System (2016), 23 descendants of its own
- K171119: GM85 (2017), 22 descendants of its own
- K173828: GU60A & GU60A-65 (2018), 19 descendants of its own

## Indications for use
Dual Energy and Tissue Equalization software options are intended for use in generating digital radiographic images of human anatomy. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K013481
Methodology: https://510kreport.com/methodology