510(k) · Cleared
ClearedDigital Radiography
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Inc. -Medical Equipment Group · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Mar 29, 2011 as substantially equivalent to K102012 (Canon Inc. -Medical Equipment Group, 2010) and 3 other predicates after a 112-day review. Its family tree reaches back 7 generations to 1998. 24 later devices descend from it.
- Decided
- Mar 29, 2011
- Review
- 112 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K981556 (1998). 13 ancestors in all. 24 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 6 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 5 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 4 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 3 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- 2 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- 1 generation backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
- This deviceK103591 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- Descendant · cites it directly · 22 of its ownK112309 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- Descendant · 2 generations on · 21 of its ownK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
- Descendant · 3 generations on · 15 of its ownK170332 Digital Radiography Cxdi-710C Wireless, Digital Radiography…Canon, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK133693 Digital Radiography Cxdi-401C WirelessCanon, Inc. · 2014
- Descendant · 4 generations on · 3 of its ownK212553 DIGITAL RADIOGRAPHY CXDI-Pro, D1Canon, Inc. · 2021
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K112309Digital RadiographyCanon Inc. -Medical Equipment Group · 2011 · cites it directly22descendants
- K131106Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital…Canon, Inc. · 2013 · 2 generations on21descendants
- K170332Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C WirelessCanon, Inc. · 2017 · 3 generations on15descendants
- K133693Digital Radiography Cxdi-401C WirelessCanon, Inc. · 2014 · cites it directly6descendants
- K212553DIGITAL RADIOGRAPHY CXDI-Pro, D1Canon, Inc. · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −6 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −5 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −4 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −3 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| −2 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| −1 | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | 1 |
| 0 (this device) | K103591 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| +1 | K112309 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| +2 | K131106 | Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG… | Canon, Inc. | 2013 | — |
| +3 | K170332 | Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C Wireless | Canon, Inc. | 2017 | — |
| +1 | K133693 | Digital Radiography Cxdi-401C Wireless | Canon, Inc. | 2014 | — |
| +4 | K212553 | DIGITAL RADIOGRAPHY CXDI-Pro, D1 | Canon, Inc. | 2021 | — |
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 |
|---|---|---|
| 2011 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K102012 | Digital RadiographySummary page 1…HY CXD1-401C COMPACT Classification Name: 90MQB, Solid State X-ray Imager FDA 510(k) #: To be assigned Predicate Device: Trade Name: Canon Inc. FDA 510(k) #/Model Name: K102012/ DIGITAL RADIOGRAPHY CXDI-70C Wireless K090623/ DIGITAL RADIOGRAPHY CXDI-40G COMPACT K062221/ DIGITAL RADIOGRAPHY CXDI-40EC K0509… | 2010 |
| * | K090623 | Digital Radiography Cxdi-40G CompactSummary page 1…, Solid State X-ray Imager FDA 510(k) #: To be assigned Predicate Device: Trade Name: Canon Inc. FDA 510(k) #/Model Name: K102012/ DIGITAL RADIOGRAPHY CXDI-70C Wireless K090623/ DIGITAL RADIOGRAPHY CXDI-40G COMPACT K062221/ DIGITAL RADIOGRAPHY CXDI-40EC K050987/ DIGITAL RADIOGRAPHY CXDI-40EG Classificatio… | 2009 |
| * | K062221 | Cxdi-40ECSummary page 1…assigned Predicate Device: Trade Name: Canon Inc. FDA 510(k) #/Model Name: K102012/ DIGITAL RADIOGRAPHY CXDI-70C Wireless K090623/ DIGITAL RADIOGRAPHY CXDI-40G COMPACT K062221/ DIGITAL RADIOGRAPHY CXDI-40EC K050987/ DIGITAL RADIOGRAPHY CXDI-40EG Classification Name: 90MQB, Solid State X-ray Imager Descr… | 2006 |
| * | K050987 | Digital Radiography Model Cxdi-40EGSummary page 1…Canon Inc. FDA 510(k) #/Model Name: K102012/ DIGITAL RADIOGRAPHY CXDI-70C Wireless K090623/ DIGITAL RADIOGRAPHY CXDI-40G COMPACT K062221/ DIGITAL RADIOGRAPHY CXDI-40EC K050987/ DIGITAL RADIOGRAPHY CXDI-40EG Classification Name: 90MQB, Solid State X-ray Imager Description of Device: The DIGITAL RADIOGRA… | 2005 |
What descends from it? (24)
See all 244 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 13 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K112309 (Canon Inc. -Medical Equipment Group, 2011) has gone furthest, with 22 descendants of its own.
- 5 other devices also cite its predicate K102012.
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. 2011, 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?
DIGITAL RADIOGRAPHY CXDI-401G, CXDI-401C, CXDI-401G COMPACT and CXDI-401C COMPACT provide digital image capture for conventional film/screen radiographic examinations.
These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
These devices are 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/K103591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103591: Digital Radiography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103591
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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