510(k) · Cleared
Recalled · Class II · 2010Digital Radiography Model Cxdi-55G
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 May 29, 2009 as substantially equivalent to K031447 (Canon, Inc., 2003) after a 15-day review. Its family tree reaches back 4 generations to 1998. 5 later devices descend from it. It has been recalled once.
- Decided
- May 29, 2009
- Review
- 15 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K981556 (1998). 5 ancestors in all. 5 later devices descend from it, 2 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 backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- This deviceK091435 Digital Radiography Model Cxdi-55GCanon, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK111682 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
- Descendant · 2 generations on · 2 of its ownK153312 Scatter Correction for Cxdi SeriesCanon, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK190368 Enhanced Feature Software Pack CXDI SeriesCanon, Inc. · 2019
- Descendant · 4 generations on · 0 of its ownK212269 Intelligent NRCanon, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK093790 Simondr DRPSimondr, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K111682Digital RadiographyCanon Inc. -Medical Equipment Group · 2011 · cites it directly3descendants
- K153312Scatter Correction for Cxdi SeriesCanon, Inc. · 2016 · 2 generations on2descendants
- K190368Enhanced Feature Software Pack CXDI SeriesCanon, Inc. · 2019 · 3 generations on1descendant
- K212269Intelligent NRCanon, Inc. · 2021 · 4 generations on0descendants
- K093790Simondr DRPSimondr, Inc. · 2010 · cites it directly0descendants
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 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| 0 (this device) | K091435 | Digital Radiography Model Cxdi-55G | Canon, Inc. | 2009 | — |
| +1 | K111682 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2011 | — |
| +2 | K153312 | Scatter Correction for Cxdi Series | Canon, Inc. | 2016 | — |
| +3 | K190368 | Enhanced Feature Software Pack CXDI Series | Canon, Inc. | 2019 | — |
| +4 | K212269 | Intelligent NR | Canon, Inc. | 2021 | — |
| +1 | K093790 | Simondr DRP | Simondr, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K031447 | Canon, Digital Radiography, Model Cxdi-50GSummary page 1…#: To be assigned Predicate Device: Manufacturer: Canon Inc. Trade Name: Canon Model Name: CXDI-50G Classification Name: 90MQB, Solid State X-ray Imager FDA 510(k) #: K031447 Description of Device: K091y35 flfl MAY 2 9 2009 The DIGITAL RADIOGRAPHY CXDI-55G is a solid state x-ray imager which has 35… | 2003 |
What descends from it? (5)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2010 | Class II | Z-2265-2012 | Nonconforming Material/Component | Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 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, K111682 (Canon Inc. -Medical Equipment Group, 2011) has gone furthest, with 3 descendants of its own.
- 15 other devices also cite its predicate K031447.
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. 2009, 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-55G 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/K091435 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091435: Digital Radiography Model Cxdi-55G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091435
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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