510(k) · Cleared
ClearedXgeo GC80
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 Jan 18, 2013 as substantially equivalent to K012389 (Ge Medical Systems, Inc., 2001) after a 108-day review. Its family tree reaches back 4 generations to 1986. 48 later devices descend from it.
- Decided
- Jan 18, 2013
- Review
- 108 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K862120 (1986). 5 ancestors in all. 48 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 3 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 2 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 1 generation backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- This deviceK123098 Xgeo GC80Samsung Electronics Co., Ltd. · 2013
- Descendant · cites it directly · 40 of its ownK140334 Xgeo GC80Samsung Electronics Co., Ltd. · 2014
- Descendant · 2 generations on · 36 of its ownK150165 GC85ASamsung Electronics Co., Ltd. · 2015
- Descendant · 3 generations on · 26 of its ownK160997 GC85ASamsung Electronics Co., Ltd. · 2016
- Descendant · 2 generations on · 25 of its ownK142492 GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd. · 2014 · Recalled
- Descendant · 3 generations on · 24 of its ownK150097 GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd. · 2015 · Recalled
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K140334Xgeo GC80Samsung Electronics Co., Ltd. · 2014 · cites it directly40descendants
- K150165GC85ASamsung Electronics Co., Ltd. · 2015 · 2 generations on36descendants
- K160997GC85ASamsung Electronics Co., Ltd. · 2016 · 3 generations on26descendants
- K142492GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd. · 2014 · 2 generations on25descendants
- K150097GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd. · 2015 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −3 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −2 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −1 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| 0 (this device) | K123098 | Xgeo GC80 | Samsung Electronics Co., Ltd. | 2013 | — |
| +1 | K140334 | Xgeo GC80 | Samsung Electronics Co., Ltd. | 2014 | — |
| +2 | K150165 | GC85A | Samsung Electronics Co., Ltd. | 2015 | — |
| +3 | K160997 | GC85A | Samsung Electronics Co., Ltd. | 2016 | — |
| +2 | K142492 | GM60A-32S, GM60A-40S | Samsung Electronics Co., Ltd. | 2014 | 1 |
| +3 | K150097 | GM60A-32S & GM60A-40S | Samsung Electronics Co., Ltd. | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 11 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 7 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K012389 | Revolution XR/D Digital Radiographic Imaging SystemSummary page 1…ate Device A. Manufacturer: General Electric Company B. Trade Nam~e: Revolution XR/d Digital Radiographic Imaging System C.510(k) Number: K01 2389 ...2/4 SAMSUNG ELECTRONICS Co., Ltd. 510(k) Premarket Notification… | 2001 |
What descends from it? (48)
See all 483 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 11.4 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K140334 (Samsung Electronics Co., Ltd., 2014) has gone furthest, with 40 descendants of its own.
- 8 other devices also cite its predicate K012389.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 GC8O 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/K123098 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123098: Xgeo GC80.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123098
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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