510(k) · Cleared
ClearedDigital Flat Panel X-Ray Detector, Model Xmaru 1717
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E-Woo Technology · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Aug 9, 2010 as substantially equivalent to K031447 (Canon, Inc., 2003) and 1 other predicate after a 480-day review. Its family tree reaches back 7 generations to 1998. 17 later devices descend from it.
- Decided
- Aug 9, 2010
- Review
- 480 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K981556 (1998). 13 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 6 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 5 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 4 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 3 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 2 generations backK090238 Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009
- 1 generation backK092830 Digital X-Ray Imaging System, Model DRC-1000VATECH Co., Ltd. · 2010
- This deviceK091090 Digital Flat Panel X-Ray Detector, Model Xmaru 1717E-Woo Technology · 2010
- Descendant · cites it directly · 13 of its ownK142475 EVS 4343DRTECH Corporation · 2015
- Descendant · 2 generations on · 7 of its ownK162555 Evs 4343, Evs 4343GDRTECH Corporation · 2016
- Descendant · 3 generations on · 6 of its ownK192400 Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation · 2019
- Descendant · 2 generations on · 4 of its ownK151942 EVS 3643DRTECH Corporation · 2015
- Descendant · 3 generations on · 3 of its ownK162552 Evs 3643, Evs 3643GDRTECH Corporation · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K142475EVS 4343DRTECH Corporation · 2015 · cites it directly13descendants
- K162555Evs 4343, Evs 4343GDRTECH Corporation · 2016 · 2 generations on7descendants
- K192400Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation · 2019 · 3 generations on6descendants
- K151942EVS 3643DRTECH Corporation · 2015 · 2 generations on4descendants
- K162552Evs 3643, Evs 3643GDRTECH Corporation · 2016 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −6 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −5 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −4 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −3 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −2 | K090238 | Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems | Sedecal., Sa. | 2009 | — |
| −1 | K092830 | Digital X-Ray Imaging System, Model DRC-1000 | VATECH Co., Ltd. | 2010 | — |
| 0 (this device) | K091090 | Digital Flat Panel X-Ray Detector, Model Xmaru 1717 | E-Woo Technology | 2010 | — |
| +1 | K142475 | EVS 4343 | DRTECH Corporation | 2015 | — |
| +2 | K162555 | Evs 4343, Evs 4343G | DRTECH Corporation | 2016 | — |
| +3 | K192400 | Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AG | DRTECH Corporation | 2019 | — |
| +2 | K151942 | EVS 3643 | DRTECH Corporation | 2015 | — |
| +3 | K162552 | Evs 3643, Evs 3643G | DRTECH Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K031447 | Canon, Digital Radiography, Model Cxdi-50GSummary page 1…l Flat Panel X-Ray Detector Classification Name : Solid State X-ray Imaging Device 3. Predicate Devices : Manufacturer : Canon Inc. Device : CXDI-50G 510(k) Number : K031447 (Decision Date - May. 21. 2003) Manufacturer : Vatech Co. Ltd Device: : DRC-1000, Digital X-ray Imaging System 510(k) Number : K… | 2003 |
| * | K092830 | Digital X-Ray Imaging System, Model DRC-1000 Cleared while this submission was under review Summary page 1L Ko41690 510(k) Submission — Xmaru1717 510(k) Summary AUG - 8 2010 ~ This summary of 510(k) safety and effectiveness information is updated citing K092830, DRC-1000, digital X-ray imaging system as a predicate and the device is a subset of components of the K092830, DRC-1000 digital… | 2010 |
What descends from it? (17)
See all 173 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 12 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K142475 (DRTECH Corporation, 2015) has gone furthest, with 13 descendants of its own.
- 15 other devices also cite its predicate K031447.
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. 2010, 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?
Xmaru1717 Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
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/K091090 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091090: Digital Flat Panel X-Ray Detector, Model Xmaru 1717.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091090
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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