510(k) · Cleared
Recalled · Class II · 2010Digital Radiography
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Inc. -Medical Equipment Group · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Aug 17, 2010 as substantially equivalent to K091545 (Canon, Inc., 2009) and 1 other predicate after a 32-day review. Its family tree reaches back 6 generations to 1998. 80 later devices descend from it. It has been recalled once.
- Decided
- Aug 17, 2010
- Review
- 32 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K981556 (1998). 9 ancestors in all. 80 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 5 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 4 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 3 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 2 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- 1 generation backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- This deviceK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010
- Descendant · cites it directly · 54 of its ownK103596 Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011
- Descendant · cites it directly · 52 of its ownK111548 Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600…Fujifilm Medical System U.S.A., Inc. · 2011
- Descendant · 2 generations on · 50 of its ownK132509 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013
- Descendant · 3 generations on · 32 of its ownK141765 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2014
- Descendant · 4 generations on · 26 of its ownK160997 GC85ASamsung Electronics Co., Ltd. · 2016
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K103596Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011 · cites it directly54descendants
- K111548Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SEFujifilm Medical System U.S.A., Inc. · 2011 · cites it directly52descendants
- K132509FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013 · 2 generations on50descendants
- K141765FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2014 · 3 generations on32descendants
- K160997GC85ASamsung Electronics Co., Ltd. · 2016 · 4 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −5 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −4 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −3 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −2 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| −1 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| 0 (this device) | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | — |
| +1 | K103596 | Wireless/Wired FDR D-Evo Flat Panel Detector | Fujifilm Medical Systems U.S.A, Inc. | 2011 | — |
| +1 | K111548 | Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE | Fujifilm Medical System U.S.A., Inc. | 2011 | — |
| +2 | K132509 | FDR D-Evo Flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2013 | — |
| +3 | K141765 | FDR D-Evo Flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| +4 | K160997 | GC85A | Samsung Electronics Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 6 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 10 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 12 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 0 |
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 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091545 | Digital Radiography Cxdi-60CSummary page 1…ay Imager FDA 510(k) #: To be assigned Predicate Device: Trade Name: Canon Inc. Model Name: CXDI-55C " Classification Name: 90MQB, Solid State X-ray lmager FDA 510(k) #: K091545 Trade Name: Canon Inc. Model Name: CXDt-31 Classification Name: 90MQB, Solid State X-ray Imager FDA 510(k) #: K003689 Description… | 2009 |
| * | K003689 | Canon X-Ray Digital Camera, Model Cxdi-31Summary page 1…Name: 90MQB, Solid State X-ray lmager FDA 510(k) #: K091545 Trade Name: Canon Inc. Model Name: CXDt-31 Classification Name: 90MQB, Solid State X-ray Imager FDA 510(k) #: K003689 Description of Device: The DIGITAL RADIOGRAPHY CXDI-70C Wireless is a solid state x-ray imager which has approx. 35x43cm imaging… | 2002 |
What descends from it? (80)
See all 806 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103596 | Wireless/Wired FDR D-Evo Flat Panel Detector | 2011 | 54 |
| K111548 | Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE | 2011 | 52 |
| K103591 | Digital Radiography | 2011 | 24 |
| K112309 | Digital Radiography | 2011 | 22 |
| K131106 | Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital… | 2013 | 21 |
| K153312 | Scatter Correction for Cxdi Series | 2016 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2010 | Class II | Z-2265-2012 | Nonconforming Material/Component | Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K103596 (Fujifilm Medical Systems U.S.A, Inc., 2011) has gone furthest, with 54 descendants of its own.
- 1 other device also cites its predicate K091545.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
Digital Radiography CXDI-70C Wireless provides digital image capture for
conventional fil/screen radiographic examinations.
The device is intended to replace radiographic film/screen systems in all general
purpose diagnostic procedures.
This device is not intended for mammography applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102012 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102012: Digital Radiography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102012
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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