510(k) · Cleared
ClearedIntelligent NR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Apr 30, 2026 as substantially equivalent to K232298 (Canon, Inc., 2024) after a 265-day review. Its family tree reaches back 12 generations to 1989.
- Decided
- Apr 30, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K890348 (1989). 81 ancestors in all, the oldest K801623 (1980). No later device cites it as a predicate yet.
- Root · 12 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 8 generations between
- 3 generations backK092439 Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc. · 2009
- 2 generations backK171194 AS-10, Cxdi-401RFCanon, Inc. · 2017
- 1 generation backK232298 DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc. · 2024
- This deviceK252503 Intelligent NRCanon, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 11 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 10 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 9 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 8 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 7 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 6 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 5 generations backK061163 Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova…Ge Medical Systems, LLC · 2006 · Recalled
- 4 generations backK091658 GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models…GE Healthcare · 2009 · Recalled
- 3 generations backK092439 Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc. · 2009
- 2 generations backK171194 AS-10, Cxdi-401RFCanon, Inc. · 2017
- 1 generation backK232298 DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc. · 2024
- This deviceK252503 Intelligent NRCanon, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −11 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −10 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −9 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −8 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −7 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −6 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −5 | K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova… | Ge Medical Systems, LLC | 2006 | 38 |
| −4 | K091658 | GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova… | GE Healthcare | 2009 | 1 |
| −3 | K092439 | Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RF | Virtual Imaging, Inc. | 2009 | — |
| −2 | K171194 | AS-10, Cxdi-401RF | Canon, Inc. | 2017 | — |
| −1 | K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | Canon, Inc. | 2024 | — |
| 0 (this device) | K252503 | Intelligent NR | Canon, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 14 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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.
What descends from it?
No later submission names this one as a predicate yet.
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 37 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 29 of the 81 ancestors have a recall of any class.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
As a part of the Canon radiography system, the CXDI Control Software when used with a compatible Canon 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. It is also used for generating…
Read the full statement (110 words)
As a part of the Canon radiography system, the CXDI Control Software when used with a compatible Canon 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.
It is also used for generating fluoroscopic images, when integrated into the X-ray diagnostic systems, to replace the spot-film devices and the X-ray image intensifiers.
As part of the CXDI Control Software, the Intelligent NR utilizes artificial intelligence based algorithms to reduce noise in fluoroscopic images.
Not intended for mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252503 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252503: Intelligent NR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252503
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026