510(k) · Cleared
ClearedCanon, Digital Radiography, Model Cxdi-50G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on May 21, 2003 as substantially equivalent to K023750 (Canon USA, Inc., 2002) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 1998. 369 later devices descend from it.
- Decided
- May 21, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K981556 (1998). 4 ancestors in all. 369 later devices descend from it, 16 citing it directly.
- Root · 3 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 2 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 1 generation backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- This deviceK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- Descendant · cites it directly · 138 of its ownK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- Descendant · cites it directly · 136 of its ownK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- Descendant · cites it directly · 91 of its ownK081648 Digital Radiography Cxdi-60GCanon, Inc. · 2008
- Descendant · 2 generations on · 82 of its ownK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- Descendant · 3 generations on · 80 of its ownK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
Showing 5 of 369 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 369 · See all- K042876Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004 · cites it directly138descendants
- K060433Digital Radiography Cxdi-50CCanon, Inc. · 2006 · cites it directly136descendants
- K081648Digital Radiography Cxdi-60GCanon, Inc. · 2008 · cites it directly91descendants
- K091545Digital Radiography Cxdi-60CCanon, Inc. · 2009 · 2 generations on82descendants
- K102012Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · 3 generations on80descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −2 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −1 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| 0 (this device) | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| +1 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| +1 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| +1 | K081648 | Digital Radiography Cxdi-60G | Canon, Inc. | 2008 | — |
| +2 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| +3 | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | 1 |
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 |
|---|---|---|
| 2004 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 9 | 0 |
| 2009 | 10 | 0 |
| 2010 | 11 | 0 |
| 2011 | 20 | 0 |
| 2012 | 12 | 0 |
| 2013 | 16 | 0 |
| 2014 | 22 | 0 |
| 2015 | 17 | 0 |
| 2016 | 24 | 0 |
| 2017 | 27 | 0 |
| 2018 | 21 | 0 |
| 2019 | 27 | 0 |
| 2020 | 30 | 0 |
| 2021 | 23 | 0 |
| 2022 | 32 | 0 |
| 2023 | 15 | 0 |
| 2024 | 16 | 0 |
| 2025 | 17 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | K023750 | Cannon Digital Radiography Model Cxdi-40GSummary page 1…Canon Model Name: CXDI - 31/CXDI- 40G Classification Name: 9OMQB, Solid State X-ray Imager FDA 510(k) #: K003689/K023750 Description Of Device: The Canon digital radiography CXDI-50G is used to directly capture and… | 2002 |
| * | K003689 | Canon X-Ray Digital Camera, Model Cxdi-31Summary page 1…Canon Model Name: CXDI - 31/CXDI- 40G Classification Name: 9OMQB, Solid State X-ray Imager FDA 510(k) #: K003689/K023750 Description Of Device: The Canon digital radiography CXDI-50G is used to directly capture and… | 2002 |
What descends from it? (369)
See all 36916 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042876 | Urs LP Digital, Millennium, Radpro | 2004 | 138 |
| K060433 | Digital Radiography Cxdi-50C | 2006 | 136 |
| K081648 | Digital Radiography Cxdi-60G | 2008 | 91 |
| K043002 | Sedecal Mobile X-Ray Units with Digital Detector | 2004 | 52 |
| K090742 | Digital Flat Panel X-Ray Detector, Model LTX240AA01-a | 2009 | 47 |
| K090238 | Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems | 2009 | 46 |
| K102587 | LLX240AB01 | 2010 | 37 |
| K042361 | Digital Portable X-Ray Units, Model SP-HF-4.0 D | 2004 | 22 |
| K091090 | Digital Flat Panel X-Ray Detector, Model Xmaru 1717 | 2010 | 17 |
| K102321 | Digital Flat Panel X-Ray Detector Model SDX-4336CP | 2011 | 11 |
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 5 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K042876 (Sedecal., Sa., 2004) has gone furthest, with 138 descendants of its own.
- 3 other devices also cite its predicate K023750.
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.
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?
CANON DIGITAL RADIOGRAPHY CXDI-50G provides digital image capture for conventional film/screen radiographic examinations.
The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031447: Canon, Digital Radiography, Model Cxdi-50G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031447
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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