510(k) Report

510(k) · Cleared

Cleared

Canon X-Ray Digital Camera Cxdi-11

K981556510(k) TraditionalCleared Nov 4, 1998187-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 Nov 4, 1998 after a 187-day review. The FDA summary names no predicate by number. 443 later devices descend from it.

Decided
Nov 4, 1998
Review
187 days
Class
Class II
Product code
MQB
Recalls
None
Predicates
0

443 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2002: 3 descendants cleared2003: 3 descendants cleared1999: 2 descendants cleared2009: 12 descendants cleared2005: 1 descendant cleared2012: 17 descendants cleared2008: 11 descendants cleared2007: 2 descendants cleared2011: 24 descendants cleared2006: 5 descendants cleared2016: 26 descendants cleared2010: 15 descendants cleared2004: 3 descendants cleared2015: 21 descendants cleared2013: 21 descendants cleared2017: 32 descendants cleared2018: 24 descendants cleared2020: 32 descendants cleared2021: 27 descendants cleared2014: 28 descendants cleared2019: 31 descendants cleared2026: 15 descendants cleared2025: 19 descendants cleared2023: 16 descendants cleared2022: 34 descendants cleared2024: 18 descendants cleared1995200020052010201520202025
  1. This deviceK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
  2. Descendant · cites it directly · 393 of its ownK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
  3. Descendant · cites it directly · 390 of its ownK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
  4. Descendant · 2 generations on · 369 of its ownK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
  5. Descendant · 2 generations on · 156 of its ownK031633 Canon Inc., Digital Radiography, Model Cxdi-40CCanon USA, Inc. · 2003
  6. Descendant · 3 generations on · 138 of its ownK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004

Showing 5 of 443 descendants. See all descendants

Descendants cleared per year

1999: 22001: 12002: 32003: 32004: 32005: 12006: 52007: 22008: 112009: 122010: 152011: 242012: 172013: 212014: 282015: 212016: 262017: 322018: 242019: 312020: 322021: 272022: 342023: 162024: 182025: 192026: 15
1999high 34 (2022) · low 0 (2000)2026

Most influential descendants

Showing 5 of 443 · See all
  • K992547Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999 · cites it directly393descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K981556Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc.1998—
+1K992547Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc.1999—
+1K023750Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc.2002—
+2K031447Canon, Digital Radiography, Model Cxdi-50GCanon, Inc.2003—
+2K031633Canon Inc., Digital Radiography, Model Cxdi-40CCanon USA, Inc.2003—
+3K042876Urs LP Digital, Millennium, RadproSedecal., Sa.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200110
200230
200330
200430
200510
200650
200720
2008110
2009120
2010150
2011240
2012170
2013210
2014280
2015210
2016260
2017320
2018240
2019310
2020320
2021270
2022340
2023160
2024180
2025190
2026150
FIG. 1 — Lineage of K981556, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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?

The FDA summary names no predicate by number.

What descends from it? (443)

See all 443

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

NumberDeviceApplicantDecidedDescendants
K992547Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc.1999393
K023750Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc.2002390
K992794Stingray DR, Model 1Infimed, Inc.1999103
K024147Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc.200378
K023586DR-ER Verfsion of Canon X-Ray Digital CamerasCanon USA, Inc.20020
K023124Canon X-Ray Digital Camera with Additional Software, Lanmix MLTCanon, Inc.20020
K012379PDX-2000 Portable Digital X-Ray SystemTrex Enterprises Corp.20010

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, K992547 (Canon USA, Inc., 1999) has gone furthest, with 393 descendants of its own.

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 X-RAY DIGITAL CAMERA CXDI-11 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.

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 MQB

The MQB category page

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  • K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp. · 2025

https://510kreport.com/device/K981556 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981556: Canon X-Ray Digital Camera Cxdi-11.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981556

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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