# K050704: Modification to:  Revolution XR/D Digital Radiographic Imaging System with Image Pasting and Autopositioning

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Apr 8, 2005 after 21 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K862120 (1986). 6 ancestors in all.
7 later devices descend from it; 1 cites 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)
- K012389: Revolution XR/D Digital Radiographic Imaging System, Ge Medical Systems, Inc. (2001). Our OCR of the scanned summary read K012388, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Revolution XR/d Digital Radiographic Imaging System”.
- K042602: Revolution XR/D Digital Radiographic Imaging System with Manual Image Pasting, Ge Medical Systems, LLC (2005) Summary page 1.

## Most influential descendants
- K143270: Optima XR646 (2015), 6 descendants of its own
- K172869: Discovery XR656 HD (2017), 5 descendants of its own
- K231892: Definium Pace Select (2023), 1 descendant of its own
- K191699: Discovery XR656 HD with VolumeRad (2019), 1 descendant of its own
- K250788: Definium Tempo Select (2025), 0 descendants of its own

## Recalls of this device
- Nov 22, 2011 · Not classified · Z-0585-2012: GE Healthcare has become aware of a potential issue associated with the patient barrier rotating arm that is a part of the Definium 8000 and Discovery XR650 image pasting systems that may impact patie
- Nov 22, 2011 · Not classified · Z-0584-2012: GE Healthcare has become aware of a potential issue associated with the patient barrier rotating arm that is a part of the Definium 8000 and Discovery XR650 image pasting systems that may impact patie

## Indications for use
Revolution XR/d Digital Radiographic Imaging System with image Pasting and Autopositioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K050704
Methodology: https://510kreport.com/methodology