510(k) · Cleared
ClearedDigital Flat Panel X-Ray Detector / 1012WCA
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 Mar 12, 2013 as substantially equivalent to K101590 (VATECH Co., Ltd., 2010) after a 132-day review. Its family tree reaches back 5 generations to 1998. 5 later devices descend from it.
- Decided
- Mar 12, 2013
- Review
- 132 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K981556 (1998). 6 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 4 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 3 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 2 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 1 generation backK101590 Digital Flat Panel X-Ray DetectorVATECH Co., Ltd. · 2010
- This deviceK123345 Digital Flat Panel X-Ray Detector / 1012WCARayence Co., Ltd. · 2013
- Descendant · cites it directly · 4 of its ownK162518 1012WCC, 1012WGCRayence Co., Ltd. · 2016
- Descendant · 2 generations on · 3 of its ownK202722 1212FCARayence Co., Ltd. · 2020
- Descendant · 3 generations on · 2 of its ownK212753 0909FCB, 1212FCARayence Co., Ltd. · 2021
- Descendant · 4 generations on · 1 of its ownK240371 0909FCC, 0909FCC-HSRayence Co., Ltd. · 2024
- Descendant · 5 generations on · 0 of its ownK253800 0909FCE, 0909FCE-HSRayence Co., Ltd. · 2026
Most influential descendants
Showing 5 of 5 · See all- K1625181012WCC, 1012WGCRayence Co., Ltd. · 2016 · cites it directly4descendants
- K2027221212FCARayence Co., Ltd. · 2020 · 2 generations on3descendants
- K2127530909FCB, 1212FCARayence Co., Ltd. · 2021 · 3 generations on2descendants
- K2403710909FCC, 0909FCC-HSRayence Co., Ltd. · 2024 · 4 generations on1descendant
- K2538000909FCE, 0909FCE-HSRayence Co., Ltd. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −4 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −3 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −2 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −1 | K101590 | Digital Flat Panel X-Ray Detector | VATECH Co., Ltd. | 2010 | — |
| 0 (this device) | K123345 | Digital Flat Panel X-Ray Detector / 1012WCA | Rayence Co., Ltd. | 2013 | — |
| +1 | K162518 | 1012WCC, 1012WGC | Rayence Co., Ltd. | 2016 | — |
| +2 | K202722 | 1212FCA | Rayence Co., Ltd. | 2020 | — |
| +3 | K212753 | 0909FCB, 1212FCA | Rayence Co., Ltd. | 2021 | — |
| +4 | K240371 | 0909FCC, 0909FCC-HS | Rayence Co., Ltd. | 2024 | — |
| +5 | K253800 | 0909FCE, 0909FCE-HS | Rayence Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K101590 | Digital Flat Panel X-Ray DetectorSummary page 2…e Device Manufacturer Rayence Co., Ltd. Device Xmarul2lOP 5 10(k) Number :K101590 (Decision Date - NOV 29. 2010) Device Description: 10I2WCA is a wired/wireless digital X-ray flat panel detector that can… | 2010 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162518 | 1012WCC, 1012WGC | 2016 | 4 |
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 15 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K162518 (Rayence Co., Ltd., 2016) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K101590.
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. 2013, 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?
IOI12WCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy 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 as stated in the FDA summary.
https://510kreport.com/device/K123345 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123345: Digital Flat Panel X-Ray Detector / 1012WCA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123345
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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