510(k) · Cleared
ClearedHAD1717MC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H&Abyz · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jan 31, 2020 as substantially equivalent to K152094 (Samsung Electronics Co., Ltd., 2015) after a 28-day review. Its family tree reaches back 7 generations to 1986.
- Decided
- Jan 31, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K862120 (1986). 8 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK200018 HAD1717MCH&Abyz · 2020
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) | K200018 | HAD1717MC | H&Abyz | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 |
|---|---|---|---|
| * | K152094 | GR40CWSummary page 4…anel: Radiology • Regulation Number: 892.1680 • Device Class: Class II • Date prepared: 01/22/2020 Primary Predicate Device • K number: K152094 • Trade Name: GR40CW • Classification Name: Stationary X-Ray System • Common Name: Digital Flat Panel X-ray Det… | 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)
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 34 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 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. 2020, 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?
Digital Flat Panel X-ray Detector, HAD1717MC 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200018: HAD1717MC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200018
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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