510(k) · Cleared
ClearedGC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85
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 May 24, 2018 as substantially equivalent to K163115 (Samsung Electronics Co., Ltd., 2016) and 6 other predicates after an 84-day review. Its family tree reaches back 15 generations to 1998. 18 later devices descend from it.
- Decided
- May 24, 2018
- Review
- 84 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 15 generations to K981556 (1998). 55 ancestors in all, the oldest K862120 (1986). 18 later devices descend from it, 5 citing it directly.
- 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 backK173828 GU60A & GU60A-65Samsung Electronics Co., Ltd. · 2018
- This deviceK180543 GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd. · 2018
- Descendant · cites it directly · 10 of its ownK181626 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2018
- Descendant · cites it directly · 5 of its ownK181631 GR40CWSamsung Electronics Co., Ltd. · 2018
- Descendant · 2 generations on · 4 of its ownK183292 Topaz Mobile DR SystemDRGEM Corporation · 2019
- Descendant · 2 generations on · 3 of its ownK220175 GM85Samsung Electronics Co., Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK203188 ADDH&abyz Co., Ltd. · 2021
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 backK173828 GU60A & GU60A-65Samsung Electronics Co., Ltd. · 2018
- This deviceK180543 GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd. · 2018
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2018 · cites it directly10descendants
- K181631GR40CWSamsung Electronics Co., Ltd. · 2018 · cites it directly5descendants
- K183292Topaz Mobile DR SystemDRGEM Corporation · 2019 · 2 generations on4descendants
- K220175GM85Samsung Electronics Co., Ltd. · 2022 · 2 generations on3descendants
- K203188ADDH&abyz Co., Ltd. · 2021 · 2 generations on3descendants
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 | K173828 | GU60A & GU60A-65 | Samsung Electronics Co., Ltd. | 2018 | — |
| 0 (this device) | K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | Samsung Electronics Co., Ltd. | 2018 | — |
| +1 | K181626 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2018 | — |
| +1 | K181631 | GR40CW | Samsung Electronics Co., Ltd. | 2018 | — |
| +2 | K183292 | Topaz Mobile DR System | DRGEM Corporation | 2019 | — |
| +2 | K220175 | GM85 | Samsung Electronics Co., Ltd. | 2022 | — |
| +2 | K203188 | ADD | H&abyz Co., Ltd. | 2021 | — |
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 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 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? (7)
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 |
|---|---|---|---|
| * | K163115 | GC70Summary page 11…ise reduction algorithm, which was cleared with K172229, to GC70, GU60&GU60A-65, GF50, GF50A, GR40CW and GM85 products which were cleared with respectively K163115, K173828, K140326, K151419, K153401 and K171119 without changes in technical characteristics. There is identical an… | 2016 |
| * | K173828 | GU60A & GU60A-65Summary page 10…0 20 0 K16311 K14032 K15141 K15340 K17111 K17222 510(K)# K173828 5 6 9 1 9 9 510(K)… | 2018 |
| * | K140326 | Xgeo GF50Summary page 11…rithm, which was cleared with K172229, to GC70, GU60&GU60A-65, GF50, GF50A, GR40CW and GM85 products which were cleared with respectively K163115, K173828, K140326, K151419, K153401 and K171119 without changes in technical characteristics. There is identical and nothing changed… | 2014 |
| * | K151419 | GF50ASummary page 11…ich was cleared with K172229, to GC70, GU60&GU60A-65, GF50, GF50A, GR40CW and GM85 products which were cleared with respectively K163115, K173828, K140326, K151419, K153401 and K171119 without changes in technical characteristics. There is identical and nothing changed in techno… | 2015 |
| * | K153401 | GR40CWSummary page 11…leared with K172229, to GC70, GU60&GU60A-65, GF50, GF50A, GR40CW and GM85 products which were cleared with respectively K163115, K173828, K140326, K151419, K153401 and K171119 without changes in technical characteristics. There is identical and nothing changed in technological c… | 2015 |
| * | K171119 | GM85Summary page 11…K172229, to GC70, GU60&GU60A-65, GF50, GF50A, GR40CW and GM85 products which were cleared with respectively K163115, K173828, K140326, K151419, K153401 and K171119 without changes in technical characteristics. There is identical and nothing changed in technological characteristic betwe… | 2017 |
| * | K172229 | GC85ASummary page 10…ance Skin Exposure (ESE) in comparison with the condition of the conventional noise reduction algorithm, is substantially equivalent. It was cleared with K172229 that using the IPE is able to reduce dose of 50% for chest PA of average adult in GC85A. This submission is purp… | 2017 |
What descends from it? (18)
See all 185 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 10 months on median.
- 16 of the 55 ancestors have a recall of any class.
- Of its descendants, K181626 (Samsung Electronics Co., Ltd., 2018) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K163115.
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 GC70 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. The GU60A & GU60A-65 Digital X-ray Imaging Systems are 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. The GF50 Digital…
Read the full statement (190 words)
The GC70 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.
The GU60A & GU60A-65 Digital X-ray Imaging Systems are 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.
The GF50 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.
The GF50A 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.
The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
The GM85 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180543: GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180543
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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