510(k) · Cleared
ClearedGR40CW
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Samsung Electronics Co., Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Dec 21, 2015 as substantially equivalent to K152094 (Samsung Electronics Co., Ltd., 2015) and 1 other predicate after a 27-day review. Its family tree reaches back 7 generations to 1986. 20 later devices descend from it.
- Decided
- Dec 21, 2015
- Review
- 27 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K862120 (1986). 14 ancestors in all. 20 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 6 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 5 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 4 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 3 generations backK123098 Xgeo GC80Samsung Electronics Co., Ltd. · 2013
- 2 generations backK140235 Xgeo GR40CWSamsung Electronics Co., Ltd. · 2014
- 1 generation backK152094 GR40CWSamsung Electronics Co., Ltd. · 2015
- This deviceK153401 GR40CWSamsung Electronics Co., Ltd. · 2015
- Descendant · cites it directly · 18 of its ownK180543 GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd. · 2018
- Descendant · 2 generations on · 10 of its ownK181626 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2018
- Descendant · 2 generations on · 5 of its ownK181631 GR40CWSamsung Electronics Co., Ltd. · 2018
- Descendant · 3 generations on · 4 of its ownK183292 Topaz Mobile DR SystemDRGEM Corporation · 2019
- Descendant · 3 generations on · 3 of its ownK220175 GM85Samsung Electronics Co., Ltd. · 2022
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd. · 2018 · cites it directly18descendants
- K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2018 · 2 generations on10descendants
- K181631GR40CWSamsung Electronics Co., Ltd. · 2018 · 2 generations on5descendants
- K183292Topaz Mobile DR SystemDRGEM Corporation · 2019 · 3 generations on4descendants
- K220175GM85Samsung Electronics Co., Ltd. · 2022 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −6 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −5 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −4 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −3 | K123098 | Xgeo GC80 | Samsung Electronics Co., Ltd. | 2013 | — |
| −2 | K140235 | Xgeo GR40CW | Samsung Electronics Co., Ltd. | 2014 | — |
| −1 | K152094 | GR40CW | Samsung Electronics Co., Ltd. | 2015 | — |
| 0 (this device) | K153401 | GR40CW | Samsung Electronics Co., Ltd. | 2015 | — |
| +1 | K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | Samsung Electronics Co., Ltd. | 2018 | — |
| +2 | K181626 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2018 | — |
| +2 | K181631 | GR40CW | Samsung Electronics Co., Ltd. | 2018 | — |
| +3 | K183292 | Topaz Mobile DR System | DRGEM Corporation | 2019 | — |
| +3 | K220175 | GM85 | Samsung Electronics Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 6 | 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 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 |
|---|---|---|---|
| * | K152094 | GR40CWSummary page 4…ager) Product Code MQB MQB Regulation 21 CFR 892.1680 21 CFR 892.1680 510(k) Number K152094 K102587 510(k) Decision Oct. 16, 2015 Dec. 01, 2… | 2015 |
| * | K102587 | LLX240AB01Summary page 4…MQB Regulation 21 CFR 892.1680 21 CFR 892.1680 510(k) Number K152094 K102587 510(k) Decision Oct. 16, 2015 Dec. 01, 2010 Date 7. Device Description… | 2010 |
What descends from it? (20)
See all 202 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 1.4 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K180543 (Samsung Electronics Co., Ltd., 2018) has gone furthest, with 18 descendants of its own.
- 1 other device also cites its predicate K152094.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153401: GR40CW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153401
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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