510(k) · Cleared
ClearedGC85A
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 Apr 2, 2015 as substantially equivalent to K140334 (Samsung Electronics Co., Ltd., 2014) after a 66-day review. Its family tree reaches back 6 generations to 1986. 36 later devices descend from it.
- Decided
- Apr 2, 2015
- Review
- 66 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K862120 (1986). 7 ancestors in all. 36 later devices descend from it, 3 citing it directly.
- 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 deviceK150165 GC85ASamsung Electronics Co., Ltd. · 2015
- Descendant · cites it directly · 26 of its ownK160997 GC85ASamsung Electronics Co., Ltd. · 2016
- Descendant · 2 generations on · 23 of its ownK163115 GC70Samsung Electronics Co., Ltd. · 2016
- Descendant · 2 generations on · 23 of its ownK162278 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016
- Descendant · 3 generations on · 22 of its ownK171119 GM85Samsung Electronics Co., Ltd. · 2017 · Recalled
- Descendant · 2 generations on · 21 of its ownK172229 GC85ASamsung Electronics Co., Ltd. · 2017
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K160997GC85ASamsung Electronics Co., Ltd. · 2016 · cites it directly26descendants
- K163115GC70Samsung Electronics Co., Ltd. · 2016 · 2 generations on23descendants
- K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016 · 2 generations on23descendants
- K171119GM85Samsung Electronics Co., Ltd. · 2017 · 3 generations on22descendants
- K172229GC85ASamsung Electronics Co., Ltd. · 2017 · 2 generations on21descendants
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) | K150165 | GC85A | Samsung Electronics Co., Ltd. | 2015 | — |
| +1 | K160997 | GC85A | Samsung Electronics Co., Ltd. | 2016 | — |
| +2 | K163115 | GC70 | Samsung Electronics Co., Ltd. | 2016 | — |
| +2 | K162278 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2016 | — |
| +3 | K171119 | GM85 | Samsung Electronics Co., Ltd. | 2017 | 1 |
| +2 | K172229 | GC85A | Samsung Electronics Co., Ltd. | 2017 | — |
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 |
|---|---|---|
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 11 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 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 |
|---|---|---|---|
| * | K140334 | Xgeo GC80Summary page 4…ONICS Co., Ltd. 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 GC85A digital X-ray imaging system consists… | 2014 |
What descends from it? (36)
See all 363 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 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.
- Of its descendants, K160997 (Samsung Electronics Co., Ltd., 2016) has gone furthest, with 26 descendants of its own.
- 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 GC85A 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/K150165 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150165: GC85A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150165
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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