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 Aug 27, 2026 as substantially equivalent to K181629 (Samsung Electronics Co., Ltd., 2018) after a 195-day review. Its family tree reaches back 15 generations to 1998.
- Decided
- Aug 27, 2026
- Review
- 195 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K981556 (1998). 46 ancestors in all, the oldest K862120 (1986). No later device cites it as a predicate yet.
- Root · 15 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 11 generations between
- 3 generations backK162278 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016
- 2 generations backK171119 GM85Samsung Electronics Co., Ltd. · 2017 · Recalled
- 1 generation backK181629 GC85ASamsung Electronics Co., Ltd. · 2018
- This deviceK260481 GC85ASamsung Electronics Co., Ltd. · 2026
Show all 15 generations
- Root · 15 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 14 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 13 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 12 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 11 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- 10 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- 9 generations backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
- 8 generations backK103596 Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011
- 7 generations backK111548 Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600…Fujifilm Medical System U.S.A., Inc. · 2011
- 6 generations backK132509 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013
- 5 generations backK141765 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2014
- 4 generations backK160997 GC85ASamsung Electronics Co., Ltd. · 2016
- 3 generations backK162278 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016
- 2 generations backK171119 GM85Samsung Electronics Co., Ltd. · 2017 · Recalled
- 1 generation backK181629 GC85ASamsung Electronics Co., Ltd. · 2018
- This deviceK260481 GC85ASamsung Electronics Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −14 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −13 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −12 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −11 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| −10 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| −9 | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | 1 |
| −8 | K103596 | Wireless/Wired FDR D-Evo Flat Panel Detector | Fujifilm Medical Systems U.S.A, Inc. | 2011 | — |
| −7 | K111548 | Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE | Fujifilm Medical System U.S.A., Inc. | 2011 | — |
| −6 | K132509 | FDR D-Evo Flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2013 | — |
| −5 | K141765 | FDR D-Evo Flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| −4 | K160997 | GC85A | Samsung Electronics Co., Ltd. | 2016 | — |
| −3 | K162278 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2016 | — |
| −2 | K171119 | GM85 | Samsung Electronics Co., Ltd. | 2017 | 1 |
| −1 | K181629 | GC85A | Samsung Electronics Co., Ltd. | 2018 | — |
| 0 (this device) | K260481 | GC85A | Samsung Electronics Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K181629 | GC85ASummary page 5…ification Name Stationary X-ray System Product Code KPR Regulation 21 CFR 892.1680 510(K)# K181629 510(K) Decision Date July 20, 2018 1 SAMSUNG… | 2018 |
| † | K242478 | GF85 (models GF85-3P, GF85-SP) | 2024 |
| † | K242651 | GM85 | 2024 |
| † | K132261 | Discovery XR656 with Volumerad (Digital Tomosynthesis) | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 16 of the 46 ancestors have a recall of any class.
- 4 other devices also cite its predicate K181629.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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/K260481 · printed Nov 3, 2026
Cite this page
510(k) Report. “K260481: GC85A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K260481
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026