510(k) · Cleared
ClearedXgeo GU60A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Samsung Electronics Co., Ltd. · KPR System, X-Ray, Stationary
Cleared on May 28, 2014 as substantially equivalent to K123106 (Samsung Electronics Co., Ltd., 2013) after a 107-day review. Its family tree reaches back 1 generation to 2013. 21 later devices descend from it.
- Decided
- May 28, 2014
- Review
- 107 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K123106 (2013). 21 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK123106 Digital Diagnostic X-Ray System Model Xgeo GU60ASamsung Electronics Co., Ltd. · 2013
- This deviceK140332 Xgeo GU60ASamsung Electronics Co., Ltd. · 2014
- Descendant · cites it directly · 20 of its ownK151685 GUA60A, GU60A-65Samsung Electronics Co., Ltd. · 2015
- Descendant · 2 generations on · 19 of its ownK173828 GU60A & GU60A-65Samsung Electronics Co., Ltd. · 2018
- Descendant · 3 generations on · 18 of its ownK180543 GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd. · 2018
- Descendant · 4 generations on · 10 of its ownK181626 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2018
- Descendant · 4 generations on · 5 of its ownK181631 GR40CWSamsung Electronics Co., Ltd. · 2018
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K151685GUA60A, GU60A-65Samsung Electronics Co., Ltd. · 2015 · cites it directly20descendants
- K173828GU60A & GU60A-65Samsung Electronics Co., Ltd. · 2018 · 2 generations on19descendants
- K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd. · 2018 · 3 generations on18descendants
- K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2018 · 4 generations on10descendants
- K181631GR40CWSamsung Electronics Co., Ltd. · 2018 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K123106 | Digital Diagnostic X-Ray System Model Xgeo GU60A | Samsung Electronics Co., Ltd. | 2013 | — |
| 0 (this device) | K140332 | Xgeo GU60A | Samsung Electronics Co., Ltd. | 2014 | — |
| +1 | K151685 | GUA60A, GU60A-65 | Samsung Electronics Co., Ltd. | 2015 | — |
| +2 | K173828 | GU60A & GU60A-65 | Samsung Electronics Co., Ltd. | 2018 | — |
| +3 | K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | Samsung Electronics Co., Ltd. | 2018 | — |
| +4 | K181626 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2018 | — |
| +4 | K181631 | GR40CW | Samsung Electronics Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 7 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 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 |
|---|---|---|---|
| * | K123106 | Digital Diagnostic X-Ray System Model Xgeo GU60ASummary page 2…8. Comparison with predicate device Samsung Electronics Co., Ltd., believes that the proposed XGEO GU60A is substantially equivalent to XGEO GU6QA (K123106). The proposed XGEO GU60A adds a new detector(S4343-W). Through the comparison with the predicate device, it… | 2013 |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151685 | GUA60A, GU60A-65 | 2015 | 20 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K151685 (Samsung Electronics Co., Ltd., 2015) has gone furthest, with 20 descendants of its own.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
The XGEO GU60A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140332: Xgeo GU60A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140332
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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