510(k) · Cleared
Recalled · Class II · 2017Digital Diagnostic X-ray System (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 Feb 4, 2015 as substantially equivalent to K140334 (Samsung Electronics Co., Ltd., 2014) after a 106-day review. Its family tree reaches back 6 generations to 1986. It has been recalled once.
- Decided
- Feb 4, 2015
- Review
- 106 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K862120 (1986). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 5 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 4 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 3 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK123098 Xgeo GC80Samsung Electronics Co., Ltd. · 2013
- 1 generation backK140334 Xgeo GC80Samsung Electronics Co., Ltd. · 2014
- This deviceK143029 Digital Diagnostic X-ray System (GC80)Samsung Electronics Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −5 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −4 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −3 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −2 | K123098 | Xgeo GC80 | Samsung Electronics Co., Ltd. | 2013 | — |
| −1 | K140334 | Xgeo GC80 | Samsung Electronics Co., Ltd. | 2014 | — |
| 0 (this device) | K143029 | Digital Diagnostic X-ray System (GC80) | Samsung Electronics Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 |
|---|---|---|---|
| * | K140334 | Xgeo GC80Summary page 5…n - Traditional B. Trade Name: XGEO GC80 C. Classification Name: System, X-ray, Stationary D. Product Code: KPR E. 510(k) Number: K140334 F. 510(k) Decision Date: May 28, 2014 7. Device Description The GC80 digital X-ray imaging system consist… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2017 | Class II | Z-0726-2018 | Other | An image was obtained with over exposure during a Thorax examination using the AEC function. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 2 other devices also cite its predicate K140334.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 GC80 Series 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/K143029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143029: Digital Diagnostic X-ray System (GC80).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143029
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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