510(k) · Cleared
ClearedIntelligent NR
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 Sep 17, 2021 as substantially equivalent to K190368 (Canon, Inc., 2019) after a 59-day review. Its family tree reaches back 13 generations to 1998.
- Decided
- Sep 17, 2021
- Review
- 59 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K981556 (1998). 50 ancestors in all, the oldest K803130 (1981). No later device cites it as a predicate yet.
- Root · 13 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 9 generations between
- 3 generations backK133693 Digital Radiography Cxdi-401C WirelessCanon, Inc. · 2014
- 2 generations backK153312 Scatter Correction for Cxdi SeriesCanon, Inc. · 2016
- 1 generation backK190368 Enhanced Feature Software Pack CXDI SeriesCanon, Inc. · 2019
- This deviceK212269 Intelligent NRCanon, Inc. · 2021
Show all 13 generations
- Root · 13 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 12 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 11 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 10 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 9 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- 8 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- 7 generations backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
- 6 generations backK103591 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- 5 generations backK112309 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- 4 generations backK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
- 3 generations backK133693 Digital Radiography Cxdi-401C WirelessCanon, Inc. · 2014
- 2 generations backK153312 Scatter Correction for Cxdi SeriesCanon, Inc. · 2016
- 1 generation backK190368 Enhanced Feature Software Pack CXDI SeriesCanon, Inc. · 2019
- This deviceK212269 Intelligent NRCanon, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −12 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −11 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −10 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −9 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| −8 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| −7 | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | 1 |
| −6 | K103591 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| −5 | K112309 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| −4 | K131106 | Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG… | Canon, Inc. | 2013 | — |
| −3 | K133693 | Digital Radiography Cxdi-401C Wireless | Canon, Inc. | 2014 | — |
| −2 | K153312 | Scatter Correction for Cxdi Series | Canon, Inc. | 2016 | — |
| −1 | K190368 | Enhanced Feature Software Pack CXDI Series | Canon, Inc. | 2019 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K190368 | Enhanced Feature Software Pack CXDI SeriesSummary page 4…em Classification: 892.1680, Stationary X-ray System Product Code: MQB Predicate Device: 510k Number: K190368 Manufacturer: Canon Inc. Trade Name: Enhanced Feature Software Pack f… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 18 of the 50 ancestors have a recall of any class.
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. 2021, 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 Canon radiography system, the CXDI Control Software when used with a compatible Canon 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/K212269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212269: Intelligent NR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212269
Report an extraction error
Are you the manufacturer?
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