510(k) · Cleared
ClearedEnhanced Feature Software Pack CXDI Series
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 Mar 13, 2019 as substantially equivalent to K153312 (Canon, Inc., 2016) and 2 other predicates after a 26-day review. Its family tree reaches back 12 generations to 1998. 1 later device descends from it.
- Decided
- Mar 13, 2019
- Review
- 26 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K981556 (1998). 49 ancestors in all, the oldest K803130 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 8 generations between
- 3 generations backK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
- 2 generations backK133693 Digital Radiography Cxdi-401C WirelessCanon, Inc. · 2014
- 1 generation backK153312 Scatter Correction for Cxdi SeriesCanon, Inc. · 2016
- This deviceK190368 Enhanced Feature Software Pack CXDI SeriesCanon, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK212269 Intelligent NRCanon, Inc. · 2021
Show all 12 generations
- Root · 12 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 11 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 10 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 9 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 8 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- 7 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- 6 generations backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
- 5 generations backK103591 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- 4 generations backK112309 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- 3 generations backK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
- 2 generations backK133693 Digital Radiography Cxdi-401C WirelessCanon, Inc. · 2014
- 1 generation backK153312 Scatter Correction for Cxdi SeriesCanon, Inc. · 2016
- This deviceK190368 Enhanced Feature Software Pack CXDI SeriesCanon, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K212269Intelligent NRCanon, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −11 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −10 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −9 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −8 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| −7 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| −6 | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | 1 |
| −5 | K103591 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| −4 | K112309 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| −3 | K131106 | Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG… | Canon, Inc. | 2013 | — |
| −2 | K133693 | Digital Radiography Cxdi-401C Wireless | Canon, Inc. | 2014 | — |
| −1 | K153312 | Scatter Correction for Cxdi Series | Canon, Inc. | 2016 | — |
| 0 (this device) | K190368 | Enhanced Feature Software Pack CXDI Series | Canon, Inc. | 2019 | — |
| +1 | K212269 | Intelligent NR | Canon, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (3)
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 |
|---|---|---|---|
| * | K153312 | Scatter Correction for Cxdi SeriesSummary page 4…igital Imager) Regulatory Number: 21 CFR 892.1680 Classification Name: Stationary X-ray system Product Code: MQB Primary Predicate #1: MQB K153312 Scatter Correction for CXDI Series Predicate #2: MQB Canon DIGITAL RADIOGRAPHY CXDI Series Detectors… | 2016 |
| * | K170332 | Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C WirelessSummary page 4…ion for CXDI Series Predicate #2: MQB Canon DIGITAL RADIOGRAPHY CXDI Series Detectors 510(k) # Models K170332 CXDI-710C Wireless K171270 CXDI-410C Wireless Device Description: The subject of this Special 5… | 2017 |
| * | K171270 | Digital Radiography Cxdi-410C WirelessSummary page 4…Canon DIGITAL RADIOGRAPHY CXDI Series Detectors 510(k) # Models K170332 CXDI-710C Wireless K171270 CXDI-410C Wireless Device Description: The subject of this Special 510(k) submission is a change to the CXDI Control… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212269 | Intelligent NR | 2021 | 0 |
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 21 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 18 of the 49 ancestors have a recall of any class.
- Of its descendants, K212269 (Canon, Inc., 2021) has gone furthest, with 0 descendants of its own.
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. 2019, 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?
As a part of the CXDI series radiography system, the CXDI Control Software when used with a compatible CXDI detector is intended to provide digital image capture, processing, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or 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/K190368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190368: Enhanced Feature Software Pack CXDI Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190368
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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