510(k) · Cleared
ClearedDigital Radiography Cxdi-60C
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 Jun 15, 2009 as substantially equivalent to K081648 (Canon, Inc., 2008) and 1 other predicate after a 19-day review. Its family tree reaches back 5 generations to 1998. 82 later devices descend from it.
- Decided
- Jun 15, 2009
- Review
- 19 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K981556 (1998). 8 ancestors in all. 82 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 4 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 3 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 2 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 1 generation backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- This deviceK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- Descendant · cites it directly · 80 of its ownK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
- Descendant · 2 generations on · 54 of its ownK103596 Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011
- Descendant · 2 generations on · 52 of its ownK111548 Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600…Fujifilm Medical System U.S.A., Inc. · 2011
- Descendant · 3 generations on · 50 of its ownK132509 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013
- Descendant · 4 generations on · 32 of its ownK141765 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2014
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 82 · See all- K102012Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · cites it directly80descendants
- K103596Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011 · 2 generations on54descendants
- K111548Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SEFujifilm Medical System U.S.A., Inc. · 2011 · 2 generations on52descendants
- K132509FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013 · 3 generations on50descendants
- K141765FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2014 · 4 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −4 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −3 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −2 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −1 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| 0 (this device) | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| +1 | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | 1 |
| +2 | K103596 | Wireless/Wired FDR D-Evo Flat Panel Detector | Fujifilm Medical Systems U.S.A, Inc. | 2011 | — |
| +2 | K111548 | Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE | Fujifilm Medical System U.S.A., Inc. | 2011 | — |
| +3 | K132509 | FDR D-Evo Flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2013 | — |
| +4 | K141765 | FDR D-Evo Flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 7 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 10 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 12 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K081648 | Digital Radiography Cxdi-60GSummary page 1…k) #: To be assigned Predicate Device: Manufacturer: Canon Inc. Trade Name: Canon Model Name: CXDI-60G Classification Name: MQB, Solid State X-ray Imager FDA S10(k) #: K081648 Predicate Device: Manufacturer: Canon Inc. Trade Name: Canon Model Name: CXDI-50C Classification Name: MQB, Solid State X-ray I… | 2008 |
| * | K060433 | Digital Radiography Cxdi-50CSummary page 1…DA S10(k) #: K081648 Predicate Device: Manufacturer: Canon Inc. Trade Name: Canon Model Name: CXDI-50C Classification Name: MQB, Solid State X-ray Imager FDA 510(k) #: K060433 Description of Device: The DIGITAL RADIOGRAPHY CXDI-60C is a solid state x-ray imager which has 23x28cm imaging area. The DIGI… | 2006 |
What descends from it? (82)
See all 822 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 11 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K102012 (Canon Inc. -Medical Equipment Group, 2010) has gone furthest, with 80 descendants of its own.
- 2 other devices also cite its predicate K081648.
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-60C 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/K091545 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091545: Digital Radiography Cxdi-60C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091545
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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