510(k) · Cleared
Recalled · Class II · 2026Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Medical Systems Corporation · OWB Interventional Fluoroscopic X-Ray System
Cleared on Apr 12, 2021 as substantially equivalent to K181804 (Canon Medical Systems Corporation, 2018) after a 17-day review. Its family tree reaches back 10 generations to 1989. 1 later device descends from it. It has been recalled 7 times.
- Decided
- Apr 12, 2021
- Review
- 17 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 10 generations to K890348 (1989). 22 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 6 generations between
- 3 generations backK113052 Infinix-CciToshiba America Medical Systems, In.C · 2011 · Recalled
- 2 generations backK152697 Infx-8000C, V6.20Toshibamedical Systems Corporation · 2016 · Recalled
- 1 generation backK181804 Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation · 2018 · Recalled
- This deviceK210900 Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation · 2021
- Descendant · cites it directly · 0 of its ownK251645 Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B…Canon Medical Systems Corporation · 2025
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 backK081621 Infx-8000C (Infinix CC-I and VC-I)Toshiba America Medical Systems, In.C · 2008 · Recalled
- 3 generations backK113052 Infinix-CciToshiba America Medical Systems, In.C · 2011 · Recalled
- 2 generations backK152697 Infx-8000C, V6.20Toshibamedical Systems Corporation · 2016 · Recalled
- 1 generation backK181804 Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation · 2018 · Recalled
- This deviceK210900 Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation · 2021
Most influential descendants
Showing 1 of 1 · See all- K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation · 2025 · cites it directly0descendants
View 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 | K081621 | Infx-8000C (Infinix CC-I and VC-I) | Toshiba America Medical Systems, In.C | 2008 | 1 |
| −3 | K113052 | Infinix-Cci | Toshiba America Medical Systems, In.C | 2011 | 1 |
| −2 | K152697 | Infx-8000C, V6.20 | Toshibamedical Systems Corporation | 2016 | 5 |
| −1 | K181804 | Alphenix, INFX-8000C/B, V8.0 | Canon Medical Systems Corporation | 2018 | 3 |
| 0 (this device) | K210900 | Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 | Canon Medical Systems Corporation | 2021 | — |
| +1 | K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B… | Canon Medical Systems Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 18.2 · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K181804 | Alphenix, INFX-8000C/B, V8.0Summary page 5…diation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard]. 14. PREDICATE DEVICE Alphenix, INFX-8000C/B, V8.0 (K181804) TABLE 1: Predicate Device Trade Proprietary Name Alphenix, INFX-8000C/B, V8.0 Market… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6… | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 12, 2026 | Not classified | Z-0289-2027 | Software design | Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use. |
| Aug 26, 2026 | Class II | Z-0108-2027 | Process control | Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error |
| Aug 4, 2026 | Class II | Z-3014-2026 | Process control | Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. |
| Dec 19, 2025 | Class II | Z-1176-2026 | Process design | It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement… |
| Sep 2, 2025 | Class II | Z-0037-2026 | Radiation Control for Health and Safety Act | It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the… |
| Nov 15, 2023 | Class II | Z-1154-2024 | Component change control | VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability… |
| Jun 22, 2023 | Class II | Z-2392-2023 | Nonconforming Material/Component | The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 8 companies; a new generation was cleared every 2.7 years on median.
- 18 of the 22 ancestors have a recall of any class.
- Of its descendants, K251645 (Canon Medical Systems Corporation, 2025) has gone furthest, with 0 descendants of its own.
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. 2021, 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?
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210900: Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210900
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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