510(k) · Cleared
Recalled · Class II · 2026Alphenix, INFX-8000F/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 Sep 28, 2018 as substantially equivalent to K081624 (Toshiba America Medical Systems, In.C, 2008) after a 24-day review. Its family tree reaches back 7 generations to 1989. It has been recalled 5 times.
- Decided
- Sep 28, 2018
- Review
- 24 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 7 generations to K890348 (1989). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 6 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 5 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 4 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 3 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 2 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 1 generation backK081624 Infx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C · 2008 · Recalled
- This deviceK182415 Alphenix, INFX-8000F/B, V8.0Canon Medical Systems Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −6 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −5 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −4 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −3 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −2 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −1 | K081624 | Infx-8000F (Infinix Csi and Infinix Dpi) | Toshiba America Medical Systems, In.C | 2008 | 8 |
| 0 (this device) | K182415 | Alphenix, INFX-8000F/B, V8.0 | Canon Medical Systems Corporation | 2018 | — |
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 |
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 |
|---|---|---|---|
| * | K081624 | Infx-8000F (Infinix Csi and Infinix Dpi)Summary page 5…Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard]. 14. PREDICATE DEVICE Primary Predicate Device: Infinix, INFX-8000F, V3.52 (K081624) Reference Predicate Device (added software functionalities): Alphenix, INFX-8000V/B, V8.0 (K181670) TABLE 1: Prima… | 2008 |
| † | K181670 | Alphenix, INFX-8000V/B, V8.0 | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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-0290-2027 | 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 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-1177-2026 | 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… |
| Nov 15, 2023 | Class II | Z-1155-2024 | 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… |
| 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 7 companies; a new generation was cleared every 2.6 years on median.
- 15 of the 19 ancestors have a recall of any class.
- 1 other device also cites its predicate K081624.
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 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/K182415 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182415: Alphenix, INFX-8000F/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/K182415
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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