510(k) · Cleared
Recalled · Class II · 2014Discovery XR656 with Volumerad (Digital Tomosynthesis)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · IZF System, X-Ray, Tomographic
Cleared on Nov 18, 2013 as substantially equivalent to K051967 (GE Healthcare, 2005) after a 122-day review. Its family tree reaches back 5 generations to 1986. 21 later devices descend from it. It has been recalled once.
- Decided
- Nov 18, 2013
- Review
- 122 days
- Class
- Class II
- Product code
- IZF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K862120 (1986). 7 ancestors in all. 21 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 4 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 3 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 2 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK051967 Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare · 2005 · Recalled
- This deviceK132261 Discovery XR656 with Volumerad (Digital Tomosynthesis)Ge Medical Systems, LLC · 2013
- Descendant · cites it directly · 8 of its ownK183275 DR 800 with TomosynthesisAgfa N.V. · 2019 · Recalled
- Descendant · cites it directly · 6 of its ownK143270 Optima XR646Ge Hualun Medical Systems Co., Ltd. · 2015
- Descendant · 2 generations on · 5 of its ownK172869 Discovery XR656 HDGe Hualun Medical Systems Co., Ltd. · 2017 · Recalled
- Descendant · cites it directly · 5 of its ownK142341 X-Ray TV System Sonialvision G4Shimadzu Corp. · 2015 · Recalled
- Descendant · 2 generations on · 4 of its ownK193262 DR 600 with TomosynthesisAgfa N.V. · 2020
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K183275DR 800 with TomosynthesisAgfa N.V. · 2019 · cites it directly8descendants
- K143270Optima XR646Ge Hualun Medical Systems Co., Ltd. · 2015 · cites it directly6descendants
- K172869Discovery XR656 HDGe Hualun Medical Systems Co., Ltd. · 2017 · 2 generations on5descendants
- K142341X-Ray TV System Sonialvision G4Shimadzu Corp. · 2015 · cites it directly5descendants
- K193262DR 600 with TomosynthesisAgfa N.V. · 2020 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −4 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −3 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −2 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −1 | K051967 | Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis | GE Healthcare | 2005 | 9 |
| 0 (this device) | K132261 | Discovery XR656 with Volumerad (Digital Tomosynthesis) | Ge Medical Systems, LLC | 2013 | — |
| +1 | K183275 | DR 800 with Tomosynthesis | Agfa N.V. | 2019 | 3 |
| +1 | K143270 | Optima XR646 | Ge Hualun Medical Systems Co., Ltd. | 2015 | — |
| +2 | K172869 | Discovery XR656 HD | Ge Hualun Medical Systems Co., Ltd. | 2017 | 1 |
| +1 | K142341 | X-Ray TV System Sonialvision G4 | Shimadzu Corp. | 2015 | 2 |
| +2 | K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IZF device
- #1 K250850 Nanox.ARC Xscore 15.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051967 | Revolution XR/D Digital Radiographic Imaging System with TomosynthesisSummary page 1…KPR, MQB and IZF Predicate Device(s): Stationary X-Ray System, MODEL: Discovery XR656 with VolumeRAD (K051967) laka Revolution XR/d with Tomosynthesis) marktedDevies:Previous name changes inc… | 2005 |
What descends from it? (21)
See all 214 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 25, 2014 | Class II | Z-2291-2014 | Nonconforming Material/Component | 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 of detector falls, but no injuries… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K183275 (Agfa N.V., 2019) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K051967.
How does its category compare?
All IZF devicesIZF System, X-Ray, Tomographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IZF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZF
Too few IZF 510(k)s in any year since 2007 to give a median.
Recalls per year · IZF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZF
1in 2021
MAUDE reports naming product code IZF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 24 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 1 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (149 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132261: Discovery XR656 with Volumerad (Digital Tomosynthesis).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132261
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026