510(k) · Cleared
Recalled · Class II · 2018GMR40
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurologica Corporation, A Subsidiary OF · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on May 11, 2017 as substantially equivalent to K153401 (Samsung Electronics Co., Ltd., 2015) after a 29-day review. Its family tree reaches back 8 generations to 1986. It has been recalled once.
- Decided
- May 11, 2017
- Review
- 29 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K862120 (1986). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 7 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 6 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 5 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 4 generations backK123098 Xgeo GC80Samsung Electronics Co., Ltd. · 2013
- 3 generations backK140235 Xgeo GR40CWSamsung Electronics Co., Ltd. · 2014
- 2 generations backK152094 GR40CWSamsung Electronics Co., Ltd. · 2015
- 1 generation backK153401 GR40CWSamsung Electronics Co., Ltd. · 2015
- This deviceK171085 GMR40Neurologica Corporation, A Subsidiary OF · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −7 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −6 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −5 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −4 | K123098 | Xgeo GC80 | Samsung Electronics Co., Ltd. | 2013 | — |
| −3 | K140235 | Xgeo GR40CW | Samsung Electronics Co., Ltd. | 2014 | — |
| −2 | K152094 | GR40CW | Samsung Electronics Co., Ltd. | 2015 | — |
| −1 | K153401 | GR40CW | Samsung Electronics Co., Ltd. | 2015 | — |
| 0 (this device) | K171085 | GMR40 | Neurologica Corporation, A Subsidiary OF | 2017 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K153401 | GR40CWSummary page 7…R40 Model # Name (predicate device Discussion (proposed device) K153401) The GMR40 Digital The GMR40 Digital X-ray Imaging X-ray Imaging… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 12, 2018 | Class II | Z-1391-2018 | Device Design | While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K153401.
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. 2017, 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 GMR40 Digital X-ray Imaging System is intended for use with portable radiographic applications wherever conventional screen-film systems or computed radiography (CR) may be used. 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/K171085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171085: GMR40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171085
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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