510(k) Report

510(k) · Cleared

Cleared

Canon X-Ray Digital Camera, Model Cxdi-31

K003689510(k) TraditionalCleared Jan 2, 2002398-day reviewClass II21 CFR 892.1630

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

Canon USA, Inc. · IXK System, Imaging, X-Ray, Electrostatic

Cleared on Jan 2, 2002 after a 398-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 371 later devices descend from it.

Decided
Jan 2, 2002
Review
398 days
Class
Class II
Product code
IXK
Recalls
None
Predicates
0

371 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2002: 1 descendant cleared2010: 11 descendants cleared2004: 3 descendants cleared2015: 17 descendants cleared2009: 10 descendants cleared2008: 9 descendants cleared2006: 3 descendants cleared2011: 20 descendants cleared2016: 24 descendants cleared2013: 16 descendants cleared2012: 12 descendants cleared2007: 1 descendant cleared2020: 30 descendants cleared2021: 23 descendants cleared2014: 22 descendants cleared2025: 17 descendants cleared2017: 27 descendants cleared2019: 27 descendants cleared2018: 21 descendants cleared2022: 32 descendants cleared2024: 16 descendants cleared2023: 15 descendants cleared2026: 13 descendants cleared200020052010201520202025
  1. This deviceK003689 Canon X-Ray Digital Camera, Model Cxdi-31Canon USA, Inc. · 2002
  2. Descendant · cites it directly · 369 of its ownK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
  3. Descendant · 2 generations on · 138 of its ownK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
  4. Descendant · 2 generations on · 136 of its ownK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
  5. Descendant · 2 generations on · 91 of its ownK081648 Digital Radiography Cxdi-60GCanon, Inc. · 2008
  6. Descendant · 3 generations on · 82 of its ownK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009

Showing 5 of 371 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 32006: 32007: 12008: 92009: 102010: 112011: 202012: 122013: 162014: 222015: 172016: 242017: 272018: 212019: 272020: 302021: 232022: 322023: 152024: 162025: 172026: 13
2002high 32 (2022) · low 0 (2005)2026

Most influential descendants

Showing 5 of 371 · See all
  • K031447Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003 · cites it directly369descendants
  • K042876Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004 · 2 generations on138descendants
  • K060433Digital Radiography Cxdi-50CCanon, Inc. · 2006 · 2 generations on136descendants
  • K081648Digital Radiography Cxdi-60GCanon, Inc. · 2008 · 2 generations on91descendants
  • K091545Digital Radiography Cxdi-60CCanon, Inc. · 2009 · 3 generations on82descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003689Canon X-Ray Digital Camera, Model Cxdi-31Canon USA, Inc.2002—
+1K031447Canon, Digital Radiography, Model Cxdi-50GCanon, Inc.2003—
+2K042876Urs LP Digital, Millennium, RadproSedecal., Sa.2004—
+2K060433Digital Radiography Cxdi-50CCanon, Inc.2006—
+2K081648Digital Radiography Cxdi-60GCanon, Inc.2008—
+3K091545Digital Radiography Cxdi-60CCanon, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200430
200630
200710
200890
2009100
2010110
2011200
2012120
2013160
2014220
2015170
2016240
2017270
2018210
2019270
2020300
2021230
2022320
2023150
2024160
2025170
2026130
FIG. 1 — Lineage of K003689, 2002–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IXK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (371)

See all 371

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

NumberDeviceApplicantDecidedDescendants
K031447Canon, Digital Radiography, Model Cxdi-50GCanon, Inc.2003369
K102012Digital RadiographyCanon Inc. -Medical Equipment Group201080
K023586DR-ER Verfsion of Canon X-Ray Digital CamerasCanon USA, Inc.20020

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?

  • Of its descendants, K031447 (Canon, Inc., 2003) has gone furthest, with 369 descendants of its own.

How does its category compare?

All IXK devices

IXK System, Imaging, X-Ray, Electrostatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IXK

1in 2011

2007: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IXK

Too few IXK 510(k)s in any year since 2007 to give a median.

Recalls per year · IXK

No recall names IXK since 2007.

Adverse event reports per year · IXK

No MAUDE report names IXK since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20111—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

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
  • K031633Canon Inc., Digital Radiography, Model Cxdi-40CCanon USA, Inc. · 2003
  • K031629Canon Non-Mydriatic Retinal Camera, Model CR-DgiCanon USA, Inc. · 2003
  • K023750Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002

Recent decisions in IXK

The IXK category page

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  • K042779Radiotherapy Solution Based on CRAgfa Corp. · 2004
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  • K000159Agfa Diagnostic Center Adc, Adc Compact, and Adc SoloAgfa Corp. · 2000

https://510kreport.com/device/K003689 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003689: Canon X-Ray Digital Camera, Model Cxdi-31.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003689

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026