# K051967: Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Aug 9, 2005 after 20 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K862120 (1986). 6 ancestors in all.
29 later devices descend from it; 2 cite it directly.
0 of 36 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.
- K944967: Tomo-Link, GE Medical Systems (1994) Summary page 1.

## Most influential descendants
- K132261: Discovery XR656 with Volumerad (Digital Tomosynthesis) (2013), 21 descendants of its own
- K183275: DR 800 with Tomosynthesis (2019), 8 descendants of its own
- K143270: Optima XR646 (2015), 6 descendants of its own
- K121499: Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System (2012), 6 descendants of its own
- K172869: Discovery XR656 HD (2017), 5 descendants of its own

## Recalls of this device
- Oct 26, 2011 · Not classified · Z-1065-2012: GE Healthcare has become aware of a potential issue associated with the hand grip that is clamped to the table top of your Revolution XRD X-ray systems that may impact patient safety. The hand grip ac
- Aug 13, 2009 · Not classified · Z-0528-2010: 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
- Mar 7, 2008 · Not classified · Z-1822-2008: Loss of image data: Software anomaly in the Processing Software on the Definium 8000 system may impact patient safety when using the VolumeRAD advanced application (option). The slice visualization of
- Mar 7, 2008 · Not classified · Z-1882-2008: Radiation dose reading greater than actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC consoles and all Definium 8000 systems may impact patie
- Feb 14, 2008 · Not classified · Z-0002-2009: GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure on Revolution XR/d systems equipped with HP 8200 PC user consoles that may impact patient safety. 
- Feb 14, 2008 · Not classified · Z-0003-2009: GE Healthcare has recently become aware of an error in the generator software on the Revolution XR/d configured with HP 8200 PC consoles that reports a mAs reading that is higher than is actually expo
- Jan 2, 2008 · Not classified · Z-1883-2008: Not properly labeling the manual switch for disabling positive beam limitation (PBL) located on the overhead tube support user interface as required
- Aug 13, 2007 · Not classified · Z-1476-2008: Necessary certification labels are missing from the x-ray contol.
- May 31, 2006 · Class II · Z-1788-2012: 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

## Indications for use
Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating Tomographic images of human anatomy. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K051967
Methodology: https://510kreport.com/methodology