510(k) · Cleared
ClearedFlat Panel Detector
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 Apr 23, 2012 after a 300-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Apr 23, 2012
- Review
- 300 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK111824 Flat Panel DetectorCanon Inc. -Medical Equipment Group · 2012
- Descendant · cites it directly · 4 of its ownK162909 CSX-30 Flat Panel DetectorCanon, Inc. – Medical Equipment Group · 2017
- Descendant · 2 generations on · 3 of its ownK171194 AS-10, Cxdi-401RFCanon, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK232298 DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK252503 Intelligent NRCanon, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK200887 AS-10Canon, Inc. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K162909CSX-30 Flat Panel DetectorCanon, Inc. – Medical Equipment Group · 2017 · cites it directly4descendants
- K171194AS-10, Cxdi-401RFCanon, Inc. · 2017 · 2 generations on3descendants
- K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc. · 2024 · 3 generations on1descendant
- K252503Intelligent NRCanon, Inc. · 2026 · 4 generations on0descendants
- K200887AS-10Canon, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111824 | Flat Panel Detector | Canon Inc. -Medical Equipment Group | 2012 | — |
| +1 | K162909 | CSX-30 Flat Panel Detector | Canon, Inc. – Medical Equipment Group | 2017 | — |
| +2 | K171194 | AS-10, Cxdi-401RF | Canon, Inc. | 2017 | — |
| +3 | K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | Canon, Inc. | 2024 | — |
| +4 | K252503 | Intelligent NR | Canon, Inc. | 2026 | — |
| +3 | K200887 | AS-10 | Canon, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K162909 (Canon, Inc. – Medical Equipment Group, 2017) has gone furthest, with 4 descendants of its own.
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. 2012, 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 | — |
https://510kreport.com/device/K111824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111824: Flat Panel Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111824
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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