510(k) · Cleared
ClearedAS-10, Cxdi-401RF
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 May 24, 2017 as substantially equivalent to K092439 (Virtual Imaging, Inc., 2009) and 1 other predicate after a 30-day review. Its family tree reaches back 10 generations to 1989. 3 later devices descend from it.
- Decided
- May 24, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K890348 (1989). 79 ancestors in all, the oldest K801623 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 6 generations between
- 3 generations backK061163 Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova…Ge Medical Systems, LLC · 2006 · Recalled
- 2 generations backK091658 GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models…GE Healthcare · 2009 · Recalled
- 1 generation backK092439 Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc. · 2009
- This deviceK171194 AS-10, Cxdi-401RFCanon, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK232298 DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK252503 Intelligent NRCanon, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK200887 AS-10Canon, Inc. · 2020
Show all 10 generations
- Root · 10 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 9 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 8 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 7 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 6 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 5 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 4 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 3 generations backK061163 Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova…Ge Medical Systems, LLC · 2006 · Recalled
- 2 generations backK091658 GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models…GE Healthcare · 2009 · Recalled
- 1 generation backK092439 Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc. · 2009
- This deviceK171194 AS-10, Cxdi-401RFCanon, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −9 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −8 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −7 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −6 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −5 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −4 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −3 | K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova… | Ge Medical Systems, LLC | 2006 | 38 |
| −2 | K091658 | GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova… | GE Healthcare | 2009 | 1 |
| −1 | K092439 | Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RF | Virtual Imaging, Inc. | 2009 | — |
| 0 (this device) | K171194 | AS-10, Cxdi-401RF | Canon, Inc. | 2017 | — |
| +1 | K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | Canon, Inc. | 2024 | — |
| +2 | K252503 | Intelligent NR | Canon, Inc. | 2026 | — |
| +1 | K200887 | AS-10 | Canon, Inc. | 2020 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K092439 | Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFSummary page 4…92.1650, Image-intensified fluoroscopic x-ray system Subsequent Product Codes: JAA, MQB Predicate Devices: Clearance: K092439 dated November 30, 2009 Manufacturer: Virtual Imaging, A Canon USA Company… | 2009 |
| * | K162909 | CSX-30 Flat Panel DetectorSummary page 4…graphic x-ray system [Originally cleared under MQB, 892.1680] Clearance: K162909 dated January 27, 2017 Manufacturer: Canon, Inc. – Medical Equipment Group… | 2017 |
What descends from it? (3)
2 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?
- The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 29 of the 79 ancestors have a recall of any class.
- Of its descendants, K232298 (Canon, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K092439.
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. 2017, 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?
The AS-10 / CXDI-401RF is indicated for use in generating fluoroscopic and radiographic images of human anatomy for angiography, diagnostic, and interventional procedures. 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/K171194 · printed Nov 5, 2026
Cite this page
510(k) Report. “K171194: AS-10, Cxdi-401RF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K171194
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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