510(k) · Cleared
ClearedMobile C-Arm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Inc. -Medical Equipment Group · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Jul 26, 2012 as substantially equivalent to K090590 (Philips Medical Systems North America Co., 2009) and 3 other predicates after an 86-day review. Its family tree reaches back 11 generations to 1989. 1 of the 89 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 26, 2012
- Review
- 86 days
- Class
- Class II
- Product code
- OXO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K890348 (1989). 88 ancestors in all, the oldest K801623 (1980). No later device cites it as a predicate yet. 1 of the 89 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 7 generations between
- 3 generations backK091658 GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models…GE Healthcare · 2009 · Recalled
- 2 generations backK092439 Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc. · 2009
- 1 generation backK093688 Canon, Model Urs-50RFVirtual Imaging, Inc. · 2010
- This deviceK121303 Mobile C-ArmCanon Inc. -Medical Equipment Group · 2012
Show all 11 generations
- Root · 11 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 10 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 9 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 8 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 7 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 6 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 5 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 4 generations backK061163 Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova…Ge Medical Systems, LLC · 2006 · Recalled
- 3 generations backK091658 GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models…GE Healthcare · 2009 · Recalled
- 2 generations backK092439 Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc. · 2009
- 1 generation backK093688 Canon, Model Urs-50RFVirtual Imaging, Inc. · 2010
- This deviceK121303 Mobile C-ArmCanon Inc. -Medical Equipment Group · 2012
Class I recalls in this family
- K021049 Oec 9800 Plus Digital Mobile Imaging Systemdirect predicate · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −10 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −9 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −8 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −7 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −6 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −5 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −4 | K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova… | Ge Medical Systems, LLC | 2006 | 38 |
| −3 | K091658 | GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova… | GE Healthcare | 2009 | 1 |
| −2 | K092439 | Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RF | Virtual Imaging, Inc. | 2009 | — |
| −1 | K093688 | Canon, Model Urs-50RF | Virtual Imaging, Inc. | 2010 | — |
| 0 (this device) | K121303 | Mobile C-Arm | Canon Inc. -Medical Equipment Group | 2012 | — |
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 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 8 | 1 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 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.
1 device in this family has a Class I recall. 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 OXO device
- #1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K090590 | Veradius, Model 718-130Summary page 1…d State X-Ray Imager (Flat Panel/Digital Imager). OXO 892.1650 Mobile Image-Intensified Fluoroscopic X-Ray System Predicate Devices: K090590 MQB Veradius, Philips K021049 JAAIOXO OEC 9800 Plus, GE Healthcare… | 2009 |
| * | K021049 | Oec 9800 Plus Digital Mobile Imaging SystemSummary page 1…OXO 892.1650 Mobile Image-Intensified Fluoroscopic X-Ray System Predicate Devices: K090590 MQB Veradius, Philips K021049 JAAIOXO OEC 9800 Plus, GE Healthcare K093688 MQB URS-5ORE, Virtual Imaging (A Ca… | 2002 |
| * | K093688 | Canon, Model Urs-50RFSummary page 1…Predicate Devices: K090590 MQB Veradius, Philips K021049 JAAIOXO OEC 9800 Plus, GE Healthcare K093688 MQB URS-5ORE, Virtual Imaging (A Canon USA Comhpany) K111824 MQB CSX-l10, Ca… | 2010 |
| * | K111824 | Flat Panel DetectorSummary page 1…JAAIOXO OEC 9800 Plus, GE Healthcare K093688 MQB URS-5ORE, Virtual Imaging (A Canon USA Comhpany) K111824 MQB CSX-l10, Canon, Inc. Device Description: The XEPHILIO MC-I 100 mobile fluoroscopy system consists of two m… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Direct predicate · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 31 of the 88 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K090590.
How does its category compare?
All OXO devicesOXO Image-Intensified Fluoroscopic X-Ray System, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OXO
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXO
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OXO
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OXO
118in 2025
MAUDE reports naming product code OXO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 48 | 4 | 5 |
| 2013 | 2 | — | 3 | 41 |
| 2014 | 2 | — | 4 | 89 |
| 2015 | 1 | — | 0 | 97 |
| 2016 | 3 | 128 | 3 | 3,820 |
| 2017 | 4 | 57 | 4 | 1,697 |
| 2018 | 1 | — | 11 | 1,647 |
| 2019 | 3 | 213 | 0 | 1,297 |
| 2020 | 0 | — | 0 | 816 |
| 2021 | 2 | — | 0 | 554 |
| 2022 | 0 | — | 0 | 295 |
| 2023 | 0 | — | 0 | 275 |
| 2024 | 2 | — | 4 | 192 |
| 2025 | 4 | 97 | 0 | 118 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The XEPHILIO MC- 100 mobile fluoroscopy system is designed to provide fluoroscopic and
spot-film radiographic images of the patient during diagnostic, surgical and interventional
procedures. Examples of clinical application may include cholangiograpby, endoscopy,
urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room
procedures. The system may be usedfor other imaging applicationsat the physician's discretion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121303: Mobile C-Arm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121303
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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