510(k) Report

510(k) · Cleared

Cleared

Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C Wireless

K170332510(k) TraditionalCleared Mar 1, 201727-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 Mar 1, 2017 as substantially equivalent to K131106 (Canon, Inc., 2013) after a 27-day review. Its family tree reaches back 10 generations to 1998. 15 later devices descend from it.

Decided
Mar 1, 2017
Review
27 days
Class
Class II
Product code
MQB
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K981556 (1998). 16 ancestors in all. 15 later devices descend from it, 5 citing it directly.

  1. Root · 10 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
  2. 6 generations between
  3. 3 generations backK103591 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
  4. 2 generations backK112309 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
  5. 1 generation backK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
  6. This deviceK170332 Digital Radiography Cxdi-710C Wireless, Digital Radiography…Canon, Inc. · 2017
  7. Descendant · cites it directly · 3 of its ownK212553 DIGITAL RADIOGRAPHY CXDI-Pro, D1Canon, Inc. · 2021
  8. Descendant · cites it directly · 3 of its ownK192632 DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY…Canon, Inc. · 2019
  9. Descendant · 2 generations on · 2 of its ownK220098 Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc. · 2022
  10. Descendant · cites it directly · 2 of its ownK213780 DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1Canon, Inc. · 2022
  11. Descendant · 2 generations on · 2 of its ownK203849 General Radiography CXDI-CS01Canon, Inc. · 2021
Show all 10 generations
  1. Root · 10 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
  2. 9 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
  3. 8 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
  4. 7 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
  5. 6 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
  6. 5 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
  7. 4 generations backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
  8. 3 generations backK103591 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
  9. 2 generations backK112309 Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
  10. 1 generation backK131106 Digital Radiography Cxdi-701C Wireless, Digital Radiography…Canon, Inc. · 2013
  11. This deviceK170332 Digital Radiography Cxdi-710C Wireless, Digital Radiography…Canon, Inc. · 2017

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2018: 12019: 22021: 32022: 82023: 1
2018high 8 (2022) · low 0 (2020)2026

Most influential descendants

Showing 5 of 15 · See all
  • K212553DIGITAL RADIOGRAPHY CXDI-Pro, D1Canon, Inc. · 2021 · cites it directly3descendants
  • K192632DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C WirelessCanon, Inc. · 2019 · cites it directly3descendants
  • K220098Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc. · 2022 · 2 generations on2descendants
  • K213780DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1Canon, Inc. · 2022 · cites it directly2descendants
  • K203849General Radiography CXDI-CS01Canon, Inc. · 2021 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K981556Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc.1998—
−9K992547Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc.1999—
−8K023750Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc.2002—
−7K031447Canon, Digital Radiography, Model Cxdi-50GCanon, Inc.2003—
−6K060433Digital Radiography Cxdi-50CCanon, Inc.2006—
−5K091545Digital Radiography Cxdi-60CCanon, Inc.2009—
−4K102012Digital RadiographyCanon Inc. -Medical Equipment Group20101
−3K103591Digital RadiographyCanon Inc. -Medical Equipment Group2011—
−2K112309Digital RadiographyCanon Inc. -Medical Equipment Group2011—
−1K131106Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG…Canon, Inc.2013—
0 (this device)K170332Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C WirelessCanon, Inc.2017—
+1K212553DIGITAL RADIOGRAPHY CXDI-Pro, D1Canon, Inc.2021—
+1K192632DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C WirelessCanon, Inc.2019—
+2K220098Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc.2022—
+1K213780DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1Canon, Inc.2022—
+2K203849General Radiography CXDI-CS01Canon, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200510
200610
200810
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201920
202130
202280
202310
FIG. 1 — Lineage of K170332, 1998–2023Source: 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
*K131106Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital…
Summary page 4
…Product Code / MQB Regulatory Standard: 892.1680 Stationary X-ray System Predicate Device: Clearance: K131106 dated July 03, 2013 Manufacturer: Canon Trade Name: DIGITAL…
Canon, Inc.2013—

Also cleared against K131106: 3 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K212553DIGITAL RADIOGRAPHY CXDI-Pro, D1Canon, Inc.20213
K192632DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C WirelessCanon, Inc.20193
K213780DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1Canon, Inc.20222
K190368Enhanced Feature Software Pack CXDI SeriesCanon, Inc.20191
K173517RADspeed fitShimadzu Corporation20181

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 19 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
  • 1 of the 16 ancestors has a recall of any class.
  • Of its descendants, K212553 (Canon, Inc., 2021) has gone furthest, with 3 descendants of its own.
  • 3 other devices also cite its predicate K131106.

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. 2017, 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?

The DIGITAL RADIOGRAPHY CXDI-710C Wireless and CXDI-810C Wireless provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K170332: Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C Wireless.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170332

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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