510(k) · Cleared
ClearedCSX-30 Flat 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 Jan 27, 2017 as substantially equivalent to K111824 (Canon Inc. -Medical Equipment Group, 2012) after a 102-day review. Its family tree reaches back 1 generation to 2012. 4 later devices descend from it.
- Decided
- Jan 27, 2017
- Review
- 102 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K111824 (2012). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK111824 Flat Panel DetectorCanon Inc. -Medical Equipment Group · 2012
- This deviceK162909 CSX-30 Flat Panel DetectorCanon, Inc. – Medical Equipment Group · 2017
- Descendant · cites it directly · 3 of its ownK171194 AS-10, Cxdi-401RFCanon, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK232298 DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK252503 Intelligent NRCanon, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK200887 AS-10Canon, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K111824 | Flat Panel Detector | Canon Inc. -Medical Equipment Group | 2012 | — |
| 0 (this device) | K162909 | CSX-30 Flat Panel Detector | Canon, Inc. – Medical Equipment Group | 2017 | — |
| +1 | K171194 | AS-10, Cxdi-401RF | Canon, Inc. | 2017 | — |
| +2 | K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | Canon, Inc. | 2024 | — |
| +3 | K252503 | Intelligent NR | Canon, Inc. | 2026 | — |
| +2 | K200887 | AS-10 | Canon, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111824 | Flat Panel DetectorSummary page 4…Product Code / MQB, JAA Regulatory Standard: 892.1680 Stationary X-ray System Predicate Device: Clearance: K111824 dated April 23, 2012 Manufacturer: Canon Trade Name: CSX-10 F… | 2012 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171194 | AS-10, Cxdi-401RF | 2017 | 3 |
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?
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. 2017, 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?
The flat panel detector CSX-30 is designed to provide fluoroscopic and spot radiographic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include angiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures or other imaging applications at the physician’s discretion. The device is intended to replace spot-film devices. The device is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162909 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162909: CSX-30 Flat Panel Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162909
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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