510(k) · Cleared
ClearedDigital Radiography Cxdi-401C Wireless
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 Jul 1, 2014 as substantially equivalent to K131106 (Canon, Inc., 2013) and 1 other predicate after a 210-day review. Its family tree reaches back 10 generations to 1998. 6 later devices descend from it.
- Decided
- Jul 1, 2014
- Review
- 210 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K981556 (1998). 16 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 6 generations between
- 3 generations backK103591 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- 2 generations backK112309 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- 1 generation backK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
- This deviceK133693 Digital Radiography Cxdi-401C WirelessCanon, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK171270 Digital Radiography Cxdi-410C WirelessCanon, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK153312 Scatter Correction for Cxdi SeriesCanon, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK241980 !M1Solutions For Tomorrow AB · 2025
- Descendant · 2 generations on · 1 of its ownK190368 Enhanced Feature Software Pack CXDI SeriesCanon, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK251710 Mobile X-ray unit (!M1)Solutions For Tomorrow AB · 2025
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 backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- 5 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- 4 generations backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
- 3 generations backK103591 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- 2 generations backK112309 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- 1 generation backK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
- This deviceK133693 Digital Radiography Cxdi-401C WirelessCanon, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K171270Digital Radiography Cxdi-410C WirelessCanon, Inc. · 2017 · cites it directly2descendants
- K153312Scatter Correction for Cxdi SeriesCanon, Inc. · 2016 · cites it directly2descendants
- K241980!M1Solutions For Tomorrow AB · 2025 · cites it directly1descendant
- K190368Enhanced Feature Software Pack CXDI SeriesCanon, Inc. · 2019 · 2 generations on1descendant
- K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB · 2025 · 2 generations on0descendants
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 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| −5 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| −4 | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | 1 |
| −3 | K103591 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| −2 | K112309 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| −1 | K131106 | Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG… | Canon, Inc. | 2013 | — |
| 0 (this device) | K133693 | Digital Radiography Cxdi-401C Wireless | Canon, Inc. | 2014 | — |
| +1 | K171270 | Digital Radiography Cxdi-410C Wireless | Canon, Inc. | 2017 | — |
| +1 | K153312 | Scatter Correction for Cxdi Series | Canon, Inc. | 2016 | — |
| +1 | K241980 | !M1 | Solutions For Tomorrow AB | 2025 | — |
| +2 | K190368 | Enhanced Feature Software Pack CXDI Series | Canon, Inc. | 2019 | — |
| +2 | K251710 | Mobile X-ray unit (!M1) | Solutions For Tomorrow AB | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K131106 | Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital…Summary page 1…ssification MQB (Solid State X-Ray Imager. Flat Panel/Digital Imager) Nanme: 892.1680 (Stationary X-Ray System) Predicate Devices: K131 106 MQB DIGIT1AL RA DIOG RA PHY CXDI-701 C Wireless. Canon, Itc. K 103591 MQB DIGITIAL RADIOGRA… | 2013 |
| * | K103591 | Digital RadiographySummary page 1…892.1680 (Stationary X-Ray System) Predicate Devices: K131 106 MQB DIGIT1AL RA DIOG RA PHY CXDI-701 C Wireless. Canon, Itc. K 103591 MQB DIGITIAL RADIOGRAPHY 'CXDI-401C COMP'ACT. Canlon. Inc. Device Description: The model of detector included in this… | 2011 |
What descends from it? (6)
3 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 16 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K171270 (Canon, Inc., 2017) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K131106.
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. 2014, 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?
The Digital Radiography CXDI-40I1C Wireless provides digital image capture for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133693: Digital Radiography Cxdi-401C Wireless.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133693
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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