510(k) · Cleared
Recalled · Class II · 2021Alphenix, INFX-8000V/B, V8.0
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 Jul 25, 2018 as substantially equivalent to K172863 (Toshibamedical Systems Corporation, 2017) after a 30-day review. Its family tree reaches back 15 generations to 1989. 4 later devices descend from it. It has been recalled once.
- Decided
- Jul 25, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 15 generations to K890348 (1989). 32 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 11 generations between
- 3 generations backK152696 Infx-8000V, V6.20Toshibamedical Systems Corporation · 2016 · Recalled
- 2 generations backK162614 Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation · 2016
- 1 generation backK172863 Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation · 2017
- This deviceK181670 Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation · 2018
- Descendant · cites it directly · 3 of its ownK203551 Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation · 2020 · Recalled
- Descendant · 2 generations on · 2 of its ownK233107 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation · 2024 · Recalled
- Descendant · 3 generations on · 1 of its ownK251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation · 2025
- Descendant · 4 generations on · 0 of its ownK253584 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV…Canon Medical Systems Corporation · 2026
Show all 15 generations
- Root · 15 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 14 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 13 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 12 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 11 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 10 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 9 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 8 generations backK081582 Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · Recalled
- 7 generations backK101868 Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010
- 6 generations backK120073 Infx-8000V withToshibamedical Systems Corporation · 2012 · Recalled
- 5 generations backK133535 Infx-8000V, V5.30Toshibamedical Systems Corporation · 2014 · Recalled
- 4 generations backK143225 INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation · 2015 · Recalled
- 3 generations backK152696 Infx-8000V, V6.20Toshibamedical Systems Corporation · 2016 · Recalled
- 2 generations backK162614 Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation · 2016
- 1 generation backK172863 Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation · 2017
- This deviceK181670 Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation · 2018
Most influential descendants
Showing 4 of 4 · See all- K203551Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation · 2020 · cites it directly3descendants
- K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation · 2024 · 2 generations on2descendants
- K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation · 2025 · 3 generations on1descendant
- K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −14 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −13 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −12 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −11 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −10 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −9 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −8 | K081582 | Infx-8000V, Infinix-Cfi and Infinix Vfi | Toshiba America Medical Systems, In.C | 2008 | 1 |
| −7 | K101868 | Infinix-I Interventional Angiography System Model Infx-8000V | Toshiba America Medical Systems, In.C | 2010 | — |
| −6 | K120073 | Infx-8000V with | Toshibamedical Systems Corporation | 2012 | 3 |
| −5 | K133535 | Infx-8000V, V5.30 | Toshibamedical Systems Corporation | 2014 | 2 |
| −4 | K143225 | INFX-8000V with Wireless Footswitch | Toshibamedical Systems Corporation | 2015 | 2 |
| −3 | K152696 | Infx-8000V, V6.20 | Toshibamedical Systems Corporation | 2016 | 1 |
| −2 | K162614 | Infinix, INFX-8000V, V6.35 | Toshibamedical Systems Corporation | 2016 | — |
| −1 | K172863 | Infinix-i, INFX-8000V, V7.0 | Toshibamedical Systems Corporation | 2017 | — |
| 0 (this device) | K181670 | Alphenix, INFX-8000V/B, V8.0 | Canon Medical Systems Corporation | 2018 | — |
| +1 | 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 |
| +3 | K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | Canon Medical Systems Corporation | 2025 | — |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K172863 | Infinix-i, INFX-8000V, V7.0Summary page 5…Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard]. 14. PREDICATE DEVICE Infinix, INFX-8000V, V7.0 (K172863) Product Marketed by 510(k) Number Clearance Da… | 2017 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203551 | Alphenix, INFX-8000V/B, /S, V9.1 | 2020 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2021 | Class II | Z-0492-2022 | Vendor change control | Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 21 of the 32 ancestors have a recall of any class.
- Of its descendants, K203551 (Canon Medical Systems Corporation, 2020) has gone furthest, with 3 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. 2018, 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 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/K181670 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181670: Alphenix, INFX-8000V/B, V8.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181670
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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