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 Jul 20, 2018 as substantially equivalent to K172229 (Samsung Electronics Co., Ltd., 2017) and 1 other predicate after a 30-day review. Its family tree reaches back 14 generations to 1998. 5 later devices descend from it.
- Decided
- Jul 20, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K981556 (1998). 45 ancestors in all, the oldest K862120 (1986). 5 later devices descend from it, 5 citing it directly.
- Root · 14 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 10 generations between
- 3 generations backK160997 GC85ASamsung Electronics Co., Ltd. · 2016
- 2 generations backK162278 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016
- 1 generation backK171119 GM85Samsung Electronics Co., Ltd. · 2017 · Recalled
- This deviceK181629 GC85ASamsung Electronics Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK260481 GC85ASamsung Electronics Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK242478 GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK182183 GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK182647 GC70Samsung Electronics Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK182622 GU60A, GU60A-65Samsung Electronics Co., Ltd. · 2018
Show all 14 generations
- Root · 14 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 13 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 12 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 11 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 10 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- 9 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- 8 generations backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
- 7 generations backK103596 Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011
- 6 generations backK111548 Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600…Fujifilm Medical System U.S.A., Inc. · 2011
- 5 generations backK132509 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013
- 4 generations backK141765 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2014
- 3 generations backK160997 GC85ASamsung Electronics Co., Ltd. · 2016
- 2 generations backK162278 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016
- 1 generation backK171119 GM85Samsung Electronics Co., Ltd. · 2017 · Recalled
- This deviceK181629 GC85ASamsung Electronics Co., Ltd. · 2018
Most influential descendants
Showing 5 of 5 · See all- K260481GC85ASamsung Electronics Co., Ltd. · 2026 · cites it directly0descendants
- K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd. · 2024 · cites it directly0descendants
- K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd. · 2018 · cites it directly0descendants
- K182647GC70Samsung Electronics Co., Ltd. · 2018 · cites it directly0descendants
- K182622GU60A, GU60A-65Samsung Electronics Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −13 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −12 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −11 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −10 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| −9 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| −8 | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | 1 |
| −7 | K103596 | Wireless/Wired FDR D-Evo Flat Panel Detector | Fujifilm Medical Systems U.S.A, Inc. | 2011 | — |
| −6 | K111548 | Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE | Fujifilm Medical System U.S.A., Inc. | 2011 | — |
| −5 | K132509 | FDR D-Evo Flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2013 | — |
| −4 | K141765 | FDR D-Evo Flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| −3 | K160997 | GC85A | Samsung Electronics Co., Ltd. | 2016 | — |
| −2 | K162278 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2016 | — |
| −1 | K171119 | GM85 | Samsung Electronics Co., Ltd. | 2017 | 1 |
| 0 (this device) | K181629 | GC85A | Samsung Electronics Co., Ltd. | 2018 | — |
| +1 | K260481 | GC85A | Samsung Electronics Co., Ltd. | 2026 | — |
| +1 | K242478 | GF85 (models GF85-3P, GF85-SP) | Samsung Electronics Co., Ltd. | 2024 | — |
| +1 | K182183 | GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A | Samsung Electronics Co., Ltd. | 2018 | — |
| +1 | K182647 | GC70 | Samsung Electronics Co., Ltd. | 2018 | — |
| +1 | K182622 | GU60A, GU60A-65 | Samsung Electronics Co., Ltd. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K172229 | GC85ASummary page 4…Product Code KPR IZL Regulation 21 CFR 892.1680 21 CFR 892.1720 510(K)# K172229 K171119 510(K) Decision Date Nov., 22, 2017 May, 12, 2017… | 2017 |
| * | K171119 | GM85Summary page 4…KPR IZL Regulation 21 CFR 892.1680 21 CFR 892.1720 510(K)# K172229 K171119 510(K) Decision Date Nov., 22, 2017 May, 12, 2017 5-1… | 2017 |
What descends from it? (5)
5 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 20 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 16 of the 45 ancestors have a recall of any class.
- Of its descendants, K260481 (Samsung Electronics Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K172229.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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/K181629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181629: GC85A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181629
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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