510(k) Report

510(k) · Cleared

Cleared

Scatter Correction for Cxdi Series

K153312510(k) TraditionalCleared Jun 28, 2016224-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, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

Cleared on Jun 28, 2016 as substantially equivalent to K102012 (Canon Inc. -Medical Equipment Group, 2010) and 6 other predicates after a 224-day review. Its family tree reaches back 11 generations to 1998. 2 later devices descend from it.

Decided
Jun 28, 2016
Review
224 days
Class
Class II
Product code
MQB
Recalls
None
Predicates
7

Its longest line of descent runs back 11 generations to K981556 (1998). 46 ancestors in all, the oldest K803130 (1981). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 1 other ancestor2011: 1 other ancestor2013: 1 other ancestor2009: 5 other ancestors2007: 2 other ancestors2006: 2 other ancestors2005: 1 other ancestor2002: 1 other ancestor2008: 2 other ancestors2003: 2 other ancestors1998: 2 other ancestors1996: 1 other ancestor1997: 2 other ancestors1995: 2 other ancestors1994: 2 other ancestors1992: 2 other ancestors2000: 1 other ancestor1999: 2 other ancestors1986: 1 other ancestor1988: 1 other ancestor1981: 1 other ancestor2019: 1 descendant cleared2021: 1 descendant 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. · 2002K031447 · Canon, Digital Radiography, Model Cxdi-50G · Canon, Inc. · 2003K060433 · Digital Radiography Cxdi-50C · Canon, Inc. · 2006K091545 · Digital Radiography Cxdi-60C · Canon, Inc. · 2009K102012 · Digital Radiography · Canon Inc. -Medical Equipment Group · 2010 · recalled×2: 2 generations cleared close together, K103591 (2011), K112309 (2011) K131106 · Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital Radiography Cxdi-801C Wireless, · Canon, Inc. · 2013K133693 · Digital Radiography Cxdi-401C Wireless · Canon, Inc. · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 8 other ancestors3 generations back: 6 other ancestors4 generations back: 7 other ancestors5 generations back: 3 other ancestors6 generations back: 4 other ancestors7 generations back: 3 other ancestors8 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K133693 · Digital Radiography Cxdi-401C Wireless · Canon, Inc. · 2014K131106 · Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital Radiography Cxdi-801C Wireless, · Canon, Inc. · 2013K112309 · Digital Radiography · Canon Inc. -Medical Equipment Group · 2011K103591 · Digital Radiography · Canon Inc. -Medical Equipment Group · 2011K102012 · Digital Radiography · Canon Inc. -Medical Equipment Group · 2010 · recalledK091545 · Digital Radiography Cxdi-60C · Canon, Inc. · 2009K060433 · Digital Radiography Cxdi-50C · Canon, Inc. · 2006K031447 · Canon, Digital Radiography, Model Cxdi-50G · Canon, Inc. · 2003K023750 · 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. · 1998−10−50
  1. Root · 11 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
  2. 7 generations between
  3. 3 generations backK112309 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
  4. 2 generations backK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
  5. 1 generation backK133693 Digital Radiography Cxdi-401C WirelessCanon, Inc. · 2014
  6. This deviceK153312 Scatter Correction for Cxdi SeriesCanon, Inc. · 2016
  7. Descendant · cites it directly · 1 of its ownK190368 Enhanced Feature Software Pack CXDI SeriesCanon, Inc. · 2019
  8. Descendant · 2 generations on · 0 of its ownK212269 Intelligent NRCanon, Inc. · 2021
Show all 11 generations
  1. Root · 11 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
  2. 10 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
  3. 9 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
  4. 8 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
  5. 7 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
  6. 6 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
  7. 5 generations backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
  8. 4 generations backK103591 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
  9. 3 generations backK112309 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
  10. 2 generations backK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
  11. 1 generation backK133693 Digital Radiography Cxdi-401C WirelessCanon, Inc. · 2014
  12. This deviceK153312 Scatter Correction for Cxdi SeriesCanon, Inc. · 2016

Most influential descendants

Showing 2 of 2 · See all
  • K190368Enhanced Feature Software Pack CXDI SeriesCanon, Inc. · 2019 · cites it directly1descendant
  • K212269Intelligent NRCanon, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K981556Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc.1998—
−10K992547Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc.1999—
−9K023750Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc.2002—
−8K031447Canon, Digital Radiography, Model Cxdi-50GCanon, Inc.2003—
−7K060433Digital Radiography Cxdi-50CCanon, Inc.2006—
−6K091545Digital Radiography Cxdi-60CCanon, Inc.2009—
−5K102012Digital RadiographyCanon Inc. -Medical Equipment Group20101
−4K103591Digital RadiographyCanon Inc. -Medical Equipment Group2011—
−3K112309Digital RadiographyCanon Inc. -Medical Equipment Group2011—
−2K131106Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG…Canon, Inc.2013—
−1K133693Digital Radiography Cxdi-401C WirelessCanon, Inc.2014—
0 (this device)K153312Scatter Correction for Cxdi SeriesCanon, Inc.2016—
+1K190368Enhanced Feature Software Pack CXDI SeriesCanon, Inc.2019—
+2K212269Intelligent NRCanon, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198610
198810
199220
199420
199520
199610
199720
199820
199920
200010
200210
200320
200510
200620
200720
200820
200950
201110
201310
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202110
FIG. 1 — Lineage of K153312, 1998–2021Source: 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? (7)

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
*K102012Digital Radiography
Summary page 4
…ystem) Predicate Devices: Predicate 1: MQB Canon DIGITAL RADIOGRAPHY CXDI Series Detectors 510(k) # Models K102012 CXDI-70C Wireless K103591 CXDI-401C, CXDI-401G, CXDI-401C Compact, CXDI-401G Compact…
Canon Inc. -Medical Equipment Group20101
*K103591Digital Radiography
Summary page 4
…Canon DIGITAL RADIOGRAPHY CXDI Series Detectors 510(k) # Models K102012 CXDI-70C Wireless K103591 CXDI-401C, CXDI-401G, CXDI-401C Compact, CXDI-401G Compact K111682 CXDI-501C, CXDI-501G…
Canon Inc. -Medical Equipment Group2011—
*K111682Digital Radiography
Summary page 4
…els K102012 CXDI-70C Wireless K103591 CXDI-401C, CXDI-401G, CXDI-401C Compact, CXDI-401G Compact K111682 CXDI-501C, CXDI-501G K112309 CXDI-80C Wireless, CXDI-80G Wireless K131106…
Canon Inc. -Medical Equipment Group2011—
*K112309Digital Radiography
Summary page 4
…K103591 CXDI-401C, CXDI-401G, CXDI-401C Compact, CXDI-401G Compact K111682 CXDI-501C, CXDI-501G K112309 CXDI-80C Wireless, CXDI-80G Wireless K131106 CXDI-701C Wireless, CXDI-701G Wireless, CXDI-801C Wir…
Canon Inc. -Medical Equipment Group2011—
*K131106Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital…
Summary page 4
…act, CXDI-401G Compact K111682 CXDI-501C, CXDI-501G K112309 CXDI-80C Wireless, CXDI-80G Wireless K131106 CXDI-701C Wireless, CXDI-701G Wireless, CXDI-801C Wireless, CXDI-801G Wireless…
Canon, Inc.2013—
*K133693Digital Radiography Cxdi-401C Wireless
Summary page 4
…K131106 CXDI-701C Wireless, CXDI-701G Wireless, CXDI-801C Wireless, CXDI-801G Wireless K133693 CXDI-401C Wireless Predicate 2: MQB / LLZ K140771 Philips Elva Workspot with Skyflow Device Description…
Canon, Inc.2014—
*K140771Philips Eleva Workspot
Summary page 4
…ess, CXDI-801C Wireless, CXDI-801G Wireless K133693 CXDI-401C Wireless Predicate 2: MQB / LLZ K140771 Philips Elva Workspot with Skyflow Device Description: The subject of this submission is a change to the CXDI Control Sof…
Philips Medical Systems Dmc GmbH2014—

Also cleared against K102012: 5 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K190368Enhanced Feature Software Pack CXDI SeriesCanon, Inc.20191

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 18 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
  • 18 of the 46 ancestors have a recall of any class.
  • Of its descendants, K190368 (Canon, Inc., 2019) has gone furthest, with 1 descendant of its own.
  • 5 other devices also cite its predicate K102012.

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. 2016, this device’s year, is highlighted.

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?

As a part of the CXDI series radiography system, the CXDI Control Software when used with a compatible CXDI detector is intended to provide digital image capture, processing, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.

Indications for use as stated in the FDA summary.

Also cleared against K102012

5 other devices cite the same predicate.

  • K131106Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital Radiography…Canon, Inc. · 2013
  • K112309Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
  • K111548Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SEFujifilm Medical System U.S.A., Inc. · 2011
  • K103591Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
  • K103596Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011

More from Canon, Inc.

43 FDA decisions under this applicant name. See the company

  • K252503Intelligent NRCanon, Inc. · 2026
  • K241049CANON Fundus Camera CR-10 (CR-10)Canon, Inc. · 2024
  • K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc. · 2024
  • K230175Digital Radiography CXDI-CS01Canon, Inc. · 2023
  • K222855Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc. · 2022

Recent decisions in MQB

The MQB category page

  • K2538000909FCE, 0909FCE-HSRayence Co., Ltd. · 2026
  • K260820Vivix-S 4386W (FXRD-4386WA)Vieworks Co., Ltd. · 2026
  • K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc. · 2026
  • K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited · 2025
  • K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp. · 2025

https://510kreport.com/device/K153312 · printed Nov 6, 2026

Cite this page

510(k) Report. “K153312: Scatter Correction for Cxdi Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153312

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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