510(k) Report

510(k) · Cleared

Cleared

Canon Inc., Digital Radiography, Model Cxdi-40C

K031633510(k) TraditionalCleared Jun 11, 200315-day reviewClass II21 CFR 892.1680

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Canon USA, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

Cleared on Jun 11, 2003 as substantially equivalent to K023750 (Canon USA, Inc., 2002) after a 15-day review. Its family tree reaches back 3 generations to 1998. 156 later devices descend from it.

Decided
Jun 11, 2003
Review
15 days
Class
Class II
Product code
MQB
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K981556 (1998). 156 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2009: 4 descendants cleared2006: 2 descendants cleared2008: 1 descendant cleared2010: 7 descendants cleared2011: 7 descendants cleared2015: 6 descendants cleared2013: 5 descendants cleared2017: 11 descendants cleared2012: 8 descendants cleared2014: 7 descendants cleared2021: 8 descendants cleared2019: 12 descendants cleared2016: 9 descendants cleared2025: 11 descendants cleared2024: 11 descendants cleared2020: 7 descendants cleared2023: 6 descendants cleared2026: 6 descendants cleared2022: 17 descendants cleared2018: 11 descendants clearedK981556 · Canon X-Ray Digital Camera Cxdi-11 · Canon USA, Inc. · 1998K992547 · Canon X-Ray Digital Camera, Model Cxdi-22 · Canon USA, Inc. · 1999K023750 · Cannon Digital Radiography Model Cxdi-40G · Canon USA, Inc. · 20021995200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 10 descendants3 generations forward: 22 descendants4 generations forward: 20 descendants5 generations forward: 20 descendants6 generations forward: 14 descendants7 generations forward: 25 descendants8 generations forward: 18 descendants9 generations forward: 7 descendants10 generations forward: 8 descendants11 generations forward: 2 descendants12 generations forward: 2 descendants13 generations forward: 2 descendants14 generations forward: 2 descendants K023750 · Cannon Digital Radiography Model Cxdi-40G · Canon USA, Inc. · 2002K992547 · Canon X-Ray Digital Camera, Model Cxdi-22 · Canon USA, Inc. · 1999K981556 · Canon X-Ray Digital Camera Cxdi-11 · Canon USA, Inc. · 19980+5+10
  1. Root · 3 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
  2. 2 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
  3. 1 generation backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
  4. This deviceK031633 Canon Inc., Digital Radiography, Model Cxdi-40CCanon USA, Inc. · 2003
  5. Descendant · cites it directly · 136 of its ownK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
  6. Descendant · 2 generations on · 82 of its ownK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
  7. Descendant · 3 generations on · 80 of its ownK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
  8. Descendant · 4 generations on · 54 of its ownK103596 Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011
  9. Descendant · 4 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

Showing 5 of 156 descendants. See all descendants

Descendants cleared per year

2006: 22008: 12009: 42010: 72011: 72012: 82013: 52014: 72015: 62016: 92017: 112018: 112019: 122020: 72021: 82022: 172023: 62024: 112025: 112026: 6
2006high 17 (2022) · low 0 (2007)2026

Most influential descendants

Showing 5 of 156 · See all
  • K060433Digital Radiography Cxdi-50CCanon, Inc. · 2006 · cites it directly136descendants
  • K091545Digital Radiography Cxdi-60CCanon, Inc. · 2009 · 2 generations on82descendants
  • K102012Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · 3 generations on80descendants
  • K103596Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011 · 4 generations on54descendants
  • K111548Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SEFujifilm Medical System U.S.A., Inc. · 2011 · 4 generations on52descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K981556Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc.1998—
−2K992547Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc.1999—
−1K023750Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc.2002—
0 (this device)K031633Canon Inc., Digital Radiography, Model Cxdi-40CCanon USA, Inc.2003—
+1K060433Digital Radiography Cxdi-50CCanon, Inc.2006—
+2K091545Digital Radiography Cxdi-60CCanon, Inc.2009—
+3K102012Digital RadiographyCanon Inc. -Medical Equipment Group20101
+4K103596Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc.2011—
+4K111548Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SEFujifilm Medical System U.S.A., Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200810
200940
201070
201170
201280
201350
201470
201560
201690
2017110
2018110
2019120
202070
202180
2022170
202360
2024110
2025110
202660
FIG. 1 — Lineage of K031633, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K023750Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc.2002—

Also cleared against K023750: 3 other devices →

What descends from it? (156)

See all 156

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060433Digital Radiography Cxdi-50CCanon, Inc.2006136
K090238Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa.200946
K062221Cxdi-40ECCanon, Inc.200625
K082347Digital Radiography, Flexdr C30Konica Minolta Technoproduct Co., Ltd.200823

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 5 years and passes through 1 company; a new generation was cleared every 11 months on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K060433 (Canon, Inc., 2006) has gone furthest, with 136 descendants of its own.
  • 3 other devices also cite its predicate K023750.

How does its category compare?

All MQB devices

MQB 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

2007: 132008: 82009: 152010: 112011: 242012: 222013: 212014: 322015: 212016: 222017: 312018: 162019: 222020: 192021: 212022: 312023: 102024: 82025: 82026 (partial year): 3
2007high 32 (2014) · low 8 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQB

127in 2025

2007: 22 days median2008: 15 days median2009: 57 days median2010: 116 days median2011: 102 days median2012: 80 days median2013: 105 days median2014: 102 days median2015: 81 days median2016: 92 days median2017: 30 days median2018: 30 days median2019: 30 days median2020: 28 days median2021: 48 days median2022: 48 days median2023: 30 days median2024: 187 days median2025: 127 days median2026 (partial year): 245 days median
2007high 245 (2026) · low 15 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQB

1in 2025

2007: 152008: 362009: 192010: 142011: 102012: 82013: 62017: 12018: 42019: 12020: 42021: 12025: 12026 (partial year): 1
2007high 36 (2008) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQB

141in 2025

2007: 252008: 302009: 342010: 392011: 1012012: 2672013: 1592014: 292015: 212016: 262017: 202018: 842019: 452020: 92021: 262022: 132023: 512024: 912025: 141
2007high 267 (2012) · low 9 (2020)2025

MAUDE reports naming product code MQB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200713221525
20088153630
200915571934
2010111161439
20112410210101
201222808267
2013211056159
201432102029
20152181021
20162292026
20173130120
20181630484
20192230145
2020192849
20212148126
20223148013
20231030051
20248187091
202581271141
202632451—

What is it indicated for?

CANON DIGITAL RADIOGRAPHY CXDI-40C 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 as stated in the FDA summary.

Also cleared against K023750

3 other devices cite the same predicate.

  • K090238Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009
  • K050987Digital Radiography Model Cxdi-40EGCanon, Inc. · 2005
  • K031447Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003

More from Canon USA, Inc.

48 FDA decisions under this applicant name. See the company

  • K090623Digital Radiography Cxdi-40G CompactCanon USA, Inc. · 2009
  • K033624Pacs Software Solution 2003Canon USA, Inc. · 2003
  • K031629Canon Non-Mydriatic Retinal Camera, Model CR-DgiCanon USA, Inc. · 2003
  • K023750Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
  • K023586DR-ER Verfsion of Canon X-Ray Digital CamerasCanon USA, Inc. · 2002

Recent decisions in MQB

The MQB category page

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  • K260820Vivix-S 4386W (FXRD-4386WA)Vieworks Co., Ltd. · 2026
  • K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc. · 2026
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  • K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp. · 2025

https://510kreport.com/device/K031633 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031633: Canon Inc., Digital Radiography, Model Cxdi-40C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031633

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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