510(k) · Cleared
ClearedAlphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
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 Mar 10, 2026 as substantially equivalent to K251602 (Canon Medical Systems Corporation, 2025) after a 113-day review. Its family tree reaches back 19 generations to 1989.
- Decided
- Mar 10, 2026
- Review
- 113 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K890348 (1989). 36 ancestors in all. No later device cites it as a predicate yet.
- Root · 19 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 15 generations between
- 3 generations backK203551 Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation · 2020 · Recalled
- 2 generations backK233107 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation · 2024 · Recalled
- 1 generation backK251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation · 2025
- This deviceK253584 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV…Canon Medical Systems Corporation · 2026
Show all 19 generations
- Root · 19 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 18 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 17 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 16 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 15 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 14 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 13 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 12 generations backK081582 Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · Recalled
- 11 generations backK101868 Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010
- 10 generations backK120073 Infx-8000V withToshibamedical Systems Corporation · 2012 · Recalled
- 9 generations backK133535 Infx-8000V, V5.30Toshibamedical Systems Corporation · 2014 · Recalled
- 8 generations backK143225 INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation · 2015 · Recalled
- 7 generations backK152696 Infx-8000V, V6.20Toshibamedical Systems Corporation · 2016 · Recalled
- 6 generations backK162614 Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation · 2016
- 5 generations backK172863 Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation · 2017
- 4 generations backK181670 Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation · 2018 · Recalled
- 3 generations backK203551 Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation · 2020 · Recalled
- 2 generations backK233107 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation · 2024 · Recalled
- 1 generation backK251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation · 2025
- This deviceK253584 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV…Canon Medical Systems Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −18 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −17 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −16 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −15 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −14 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −13 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −12 | K081582 | Infx-8000V, Infinix-Cfi and Infinix Vfi | Toshiba America Medical Systems, In.C | 2008 | 1 |
| −11 | K101868 | Infinix-I Interventional Angiography System Model Infx-8000V | Toshiba America Medical Systems, In.C | 2010 | — |
| −10 | K120073 | Infx-8000V with | Toshibamedical Systems Corporation | 2012 | 3 |
| −9 | K133535 | Infx-8000V, V5.30 | Toshibamedical Systems Corporation | 2014 | 2 |
| −8 | K143225 | INFX-8000V with Wireless Footswitch | Toshibamedical Systems Corporation | 2015 | 2 |
| −7 | K152696 | Infx-8000V, V6.20 | Toshibamedical Systems Corporation | 2016 | 1 |
| −6 | K162614 | Infinix, INFX-8000V, V6.35 | Toshibamedical Systems Corporation | 2016 | — |
| −5 | K172863 | Infinix-i, INFX-8000V, V7.0 | Toshibamedical Systems Corporation | 2017 | — |
| −4 | K181670 | Alphenix, INFX-8000V/B, V8.0 | Canon Medical Systems Corporation | 2018 | 1 |
| −3 | K203551 | Alphenix, INFX-8000V/B, /S, V9.1 | Canon Medical Systems Corporation | 2020 | 2 |
| −2 | K233107 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 | Canon Medical Systems Corporation | 2024 | 3 |
| −1 | K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | Canon Medical Systems Corporation | 2025 | — |
| 0 (this device) | K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Canon Medical Systems Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingSummary page 6…Trade Name with αEvolve Imaging Marketed by Canon Medical Systems USA, Inc. 510(k) Number K251602 Clearance Date October 10, 2025 Common Name Interventional Fluoroscopic X-ray System… | 2025 |
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 8 companies; a new generation was cleared every 1.2 years on median.
- 24 of the 36 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?
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.
aEvolve Imaging is an imaging chain intended for adults, with Artificial Intelligence Denoising (AID) designed to reduce noise in real-time fluoroscopic images and signal enhancement algorithm, Multi Frequency Processing (MFP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253584 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253584: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253584
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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