# K132261: Discovery XR656 with Volumerad (Digital Tomosynthesis)

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Nov 18, 2013 after 122 days
- Product code: IZF (System, X-Ray, Tomographic)
- Device class: 2
- Regulation: 21 CFR 892.1740
- Recalls of this device: 1 (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). 7 ancestors in all.
21 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051967: Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis, GE Healthcare (2005) Summary page 1.

## Most influential descendants
- K183275: DR 800 with Tomosynthesis (2019), 8 descendants of its own
- K143270: Optima XR646 (2015), 6 descendants of its own
- K172869: Discovery XR656 HD (2017), 5 descendants of its own
- K142341: X-Ray TV System Sonialvision G4 (2015), 5 descendants of its own
- K193262: DR 600 with Tomosynthesis (2020), 4 descendants of its own

## Recalls of this device
- Jul 25, 2014 · Class II · Z-2291-2014: GE Healthcare has become aware of a potential safety issue involving the nylon hooks which support the FlashPad" detector on the Discovery XR656 wall stand systems. There have been reported incidents 

## Indications for use
The Discovery XR656 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of al ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and is intended for use in all routine radiography exams. When the VolumeRAD option is included on the system, the system can generate tomographic images of human anatomy including the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. When the VolumeRAD option is used for patients undergoing thoracic imaging, it is indicated for the detection of lung nodules. VolumeRad generates diagnostic images of the chest that aid the radiologist in achieving superior detectability of lung nodules versus posterior-anterior and left lateral views of the chest, at a comparable radiation level. The device is not intended for mammogrophic applications.

Source page: https://510kreport.com/device/K132261
Methodology: https://510kreport.com/methodology