510(k) · Cleared
ClearedCxdi-40EC
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 Aug 17, 2006 as substantially equivalent to K050987 (Canon, Inc., 2005) and 1 other predicate after a 15-day review. Its family tree reaches back 4 generations to 1998. 25 later devices descend from it.
- Decided
- Aug 17, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K981556 (1998). 5 ancestors in all. 25 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 3 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 2 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 1 generation backK031633 Canon Inc., Digital Radiography, Model Cxdi-40CCanon USA, Inc. · 2003
- This deviceK062221 Cxdi-40ECCanon, Inc. · 2006
- Descendant · cites it directly · 24 of its ownK103591 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- Descendant · 2 generations on · 22 of its ownK112309 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- Descendant · 3 generations on · 21 of its ownK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
- Descendant · 4 generations on · 15 of its ownK170332 Digital Radiography Cxdi-710C Wireless, Digital Radiography…Canon, Inc. · 2017
- Descendant · 2 generations on · 6 of its ownK133693 Digital Radiography Cxdi-401C WirelessCanon, Inc. · 2014
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K103591Digital RadiographyCanon Inc. -Medical Equipment Group · 2011 · cites it directly24descendants
- K112309Digital RadiographyCanon Inc. -Medical Equipment Group · 2011 · 2 generations on22descendants
- K131106Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital…Canon, Inc. · 2013 · 3 generations on21descendants
- K170332Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C WirelessCanon, Inc. · 2017 · 4 generations on15descendants
- K133693Digital Radiography Cxdi-401C WirelessCanon, Inc. · 2014 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −3 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −2 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −1 | K031633 | Canon Inc., Digital Radiography, Model Cxdi-40C | Canon USA, Inc. | 2003 | — |
| 0 (this device) | K062221 | Cxdi-40EC | Canon, Inc. | 2006 | — |
| +1 | K103591 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| +2 | K112309 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| +3 | K131106 | Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG… | Canon, Inc. | 2013 | — |
| +4 | K170332 | Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C Wireless | Canon, Inc. | 2017 | — |
| +2 | K133693 | Digital Radiography Cxdi-401C Wireless | Canon, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K050987 | Digital Radiography Model Cxdi-40EGSummary page 1…ssigned Predicate Device: Maanufacturer: Canon Inc. Trade Name: Canon . Model Name: CXDI-40EG/CXDI-40C Classification Name: 90MQB, Solid State X-ray Imager FDA 510(k) #: K050987/ K031633 Description Of Device: The Canon digital radiography CXDI-40EC is used to directly capture and convert conventional pr… | 2005 |
| * | K031633 | Canon Inc., Digital Radiography, Model Cxdi-40CSummary page 1…redicate Device: Maanufacturer: Canon Inc. Trade Name: Canon . Model Name: CXDI-40EG/CXDI-40C Classification Name: 90MQB, Solid State X-ray Imager FDA 510(k) #: K050987/ K031633 Description Of Device: The Canon digital radiography CXDI-40EC is used to directly capture and convert conventional projection… | 2003 |
What descends from it? (25)
See all 251 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103591 | Digital Radiography | 2011 | 24 |
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 8 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K103591 (Canon Inc. -Medical Equipment Group, 2011) has gone furthest, with 24 descendants of its own.
- 3 other devices also cite its predicate K050987.
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?
DIGITAL RADIOGRAPHY CXDI-40EC 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. This device is not intended for mammography applications.
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/K062221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062221: Cxdi-40EC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062221
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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