510(k) · Cleared
ClearedCanon X-Ray Digital Camera, Model Cxdi-22
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon USA, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Oct 13, 1999 as substantially equivalent to K981556 (Canon USA, Inc., 1998) after a 75-day review. Its family tree reaches back 1 generation to 1998. 393 later devices descend from it.
- Decided
- Oct 13, 1999
- Review
- 75 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981556 (1998). 393 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- This deviceK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- Descendant · cites it directly · 390 of its ownK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- Descendant · 2 generations on · 369 of its ownK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- Descendant · 2 generations on · 156 of its ownK031633 Canon Inc., Digital Radiography, Model Cxdi-40CCanon USA, Inc. · 2003
- Descendant · 3 generations on · 138 of its ownK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- Descendant · 3 generations on · 136 of its ownK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
Showing 5 of 393 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 393 · See all- K023750Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002 · cites it directly390descendants
- K031447Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003 · 2 generations on369descendants
- K031633Canon Inc., Digital Radiography, Model Cxdi-40CCanon USA, Inc. · 2003 · 2 generations on156descendants
- K042876Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004 · 3 generations on138descendants
- K060433Digital Radiography Cxdi-50CCanon, Inc. · 2006 · 3 generations on136descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| 0 (this device) | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| +1 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| +2 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| +2 | K031633 | Canon Inc., Digital Radiography, Model Cxdi-40C | Canon USA, Inc. | 2003 | — |
| +3 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| +3 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 10 | 0 |
| 2009 | 10 | 0 |
| 2010 | 12 | 0 |
| 2011 | 20 | 0 |
| 2012 | 15 | 0 |
| 2013 | 17 | 0 |
| 2014 | 23 | 0 |
| 2015 | 19 | 0 |
| 2016 | 25 | 0 |
| 2017 | 28 | 0 |
| 2018 | 22 | 0 |
| 2019 | 27 | 0 |
| 2020 | 30 | 0 |
| 2021 | 24 | 0 |
| 2022 | 34 | 0 |
| 2023 | 15 | 0 |
| 2024 | 17 | 0 |
| 2025 | 18 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | K981556 | Canon X-Ray Digital Camera Cxdi-11Summary page 1…28-5602 (516) 328-5169 New Model Canon Inc. Canon CXDI-22 MQB, Solid State X-ray Imager To be assigned Canon Inc. Canon ‘CXDI-11 90MQB, Solid State X-ray Imager K981556 The Canon X-ray digital camera model CXDI-22 is used to directly capture and convert conventional projection X-ray images to dig… | 1998 |
What descends from it? (393)
See all 3933 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?
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?
CANON X~RAY DIGITAL CAMERA CXDI-22 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.
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/K992547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992547: Canon X-Ray Digital Camera, Model Cxdi-22.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992547
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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