# K012389: Revolution XR/D Digital Radiographic Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Aug 10, 2001 after 14 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K862120 (1986). 4 ancestors in all.
103 later devices descend from it; 9 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992066: Revolution TX/I Digital Radiographic Table System, GE Medical Systems (1999) Summary page 2.

## Most influential descendants
- K123098: Xgeo GC80 (2013), 48 descendants of its own
- K013481: Dual Energy and Tissue Equalization Software Option (2001), 45 descendants of its own
- K140334: Xgeo GC80 (2014), 40 descendants of its own
- K150165: GC85A (2015), 36 descendants of its own
- K092363: Softview, Model 2.01 (2010), 34 descendants of its own

## Recalls of this device
- Jun 4, 2014 · Class II · Z-1989-2014: GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging sys
- Aug 13, 2009 · Not classified · Z-0527-2010: Certain GE Radiographic fixed X-ray tables (Proteus XR/a, Revolution XR/d, and Definium 8000) were found to have tabletops that move unexpectedly in a bi-directional mode. In rare cases, a malfunction
- May 31, 2006 · Class II · Z-1789-2012: An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge a
- Nov 21, 2002 · Not classified · Z-0157-03: The devices do not meet requirements in 21 CFR 1010.2 in that they lack certification labels.

## Indications for use
The Revolution XR/d Digital Radiographic X-ray System is indicated for use in generating radiographic images of human anatomy. It is intended for use in replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K012389
Methodology: https://510kreport.com/methodology