510(k) · Cleared
ClearedDigital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rayence Co., Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Sep 9, 2024 as substantially equivalent to K231467 (Rayence Co., Ltd., 2023) after a 27-day review. Its family tree reaches back 9 generations to 1998.
- Decided
- Sep 9, 2024
- Review
- 27 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K981556 (1998). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 5 generations between
- 3 generations backK130935 Digital Flat Panel X-Ray Detector/1417WCARayence Co., Ltd. · 2013
- 2 generations backK171418 1417WCC_127um and1417WCC_140umRayence Co., Ltd. · 2017
- 1 generation backK231467 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFRayence Co., Ltd. · 2023
- This deviceK242394 Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS…Rayence Co., Ltd. · 2024
Show all 9 generations
- Root · 9 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 8 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 7 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 6 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 5 generations backK102321 Digital Flat Panel X-Ray Detector Model SDX-4336CPSamsung Mobile Display Co., Ltd. · 2011
- 4 generations backK122919 Digital Flat Panel X-Ray DETECTOR11417PCARayence Co., Ltd. · 2013
- 3 generations backK130935 Digital Flat Panel X-Ray Detector/1417WCARayence Co., Ltd. · 2013
- 2 generations backK171418 1417WCC_127um and1417WCC_140umRayence Co., Ltd. · 2017
- 1 generation backK231467 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFRayence Co., Ltd. · 2023
- This deviceK242394 Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS…Rayence Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −8 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −7 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −6 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −5 | K102321 | Digital Flat Panel X-Ray Detector Model SDX-4336CP | Samsung Mobile Display Co., Ltd. | 2011 | — |
| −4 | K122919 | Digital Flat Panel X-Ray DETECTOR11417PCA | Rayence Co., Ltd. | 2013 | — |
| −3 | K130935 | Digital Flat Panel X-Ray Detector/1417WCA | Rayence Co., Ltd. | 2013 | — |
| −2 | K171418 | 1417WCC_127um and1417WCC_140um | Rayence Co., Ltd. | 2017 | — |
| −1 | K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | Rayence Co., Ltd. | 2023 | — |
| 0 (this device) | K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Rayence Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFSummary page 5…: Digital Flat Panel X-ray Detector (Model: 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF) 510(k) Number : K231467 Regulation Number : 21 CFR 892.1680 Regulation Name : Stationary X-ray System Regulatory Class… | 2023 |
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 26 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 10 ancestors has a recall.
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. 2024, 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 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 as stated in the FDA summary.
https://510kreport.com/device/K242394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242394: Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242394
Report an extraction error
Are you the manufacturer?
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