510(k) · Cleared
Cleared0909FCE, 0909FCE-HS
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 Jul 31, 2026 as substantially equivalent to K240371 (Rayence Co., Ltd., 2024) after a 245-day review. Its family tree reaches back 10 generations to 1998.
- Decided
- Jul 31, 2026
- Review
- 245 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K981556 (1998). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 6 generations between
- 3 generations backK202722 1212FCARayence Co., Ltd. · 2020
- 2 generations backK212753 0909FCB, 1212FCARayence Co., Ltd. · 2021
- 1 generation backK240371 0909FCC, 0909FCC-HSRayence Co., Ltd. · 2024
- This deviceK253800 0909FCE, 0909FCE-HSRayence Co., Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 9 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 8 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 7 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 6 generations backK101590 Digital Flat Panel X-Ray DetectorVATECH Co., Ltd. · 2010
- 5 generations backK123345 Digital Flat Panel X-Ray Detector / 1012WCARayence Co., Ltd. · 2013
- 4 generations backK162518 1012WCC, 1012WGCRayence Co., Ltd. · 2016
- 3 generations backK202722 1212FCARayence Co., Ltd. · 2020
- 2 generations backK212753 0909FCB, 1212FCARayence Co., Ltd. · 2021
- 1 generation backK240371 0909FCC, 0909FCC-HSRayence Co., Ltd. · 2024
- This deviceK253800 0909FCE, 0909FCE-HSRayence Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −9 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −8 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −7 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −6 | K101590 | Digital Flat Panel X-Ray Detector | VATECH Co., Ltd. | 2010 | — |
| −5 | K123345 | Digital Flat Panel X-Ray Detector / 1012WCA | Rayence Co., Ltd. | 2013 | — |
| −4 | K162518 | 1012WCC, 1012WGC | Rayence Co., Ltd. | 2016 | — |
| −3 | K202722 | 1212FCA | Rayence Co., Ltd. | 2020 | — |
| −2 | K212753 | 0909FCB, 1212FCA | Rayence Co., Ltd. | 2021 | — |
| −1 | K240371 | 0909FCC, 0909FCC-HS | Rayence Co., Ltd. | 2024 | — |
| 0 (this device) | K253800 | 0909FCE, 0909FCE-HS | Rayence Co., Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K240371 | 0909FCC, 0909FCC-HSSummary page 5…de/Device Name : 0909FCC, 0909FCC-HS Common Name : Digital Flat Panel X-ray Detector 510(k) Number : K240371 Regulation Number : 21 CFR 892.1680 Regulation Name : Stationary X-ray System… | 2024 |
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 28 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 11 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. 2026, 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?
0909FCE and 0909FCE-HS are indicated for digital imaging solution designed including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. 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/K253800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253800: 0909FCE, 0909FCE-HS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253800
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026