510(k) · Cleared
ClearedXIDF - AWS801, Angio Workstation (Alphenix Workstation), 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 10, 2018 as substantially equivalent to K172646 (Toshibamedical Systems Corporation, 2017) after a 103-day review. Its family tree reaches back 16 generations to 1989. 2 later devices descend from it.
- Decided
- Sep 10, 2018
- Review
- 103 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K890348 (1989). 53 ancestors in all, the oldest K853753 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 12 generations between
- 3 generations backK150967 XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation · 2015 · Recalled
- 2 generations backK152785 XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation · 2015 · Recalled
- 1 generation backK172646 XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation · 2017
- This deviceK181415 XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation · 2018
- Descendant · cites it directly · 1 of its ownK220342 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK232526 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation · 2023
Show all 16 generations
- Root · 16 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 15 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 14 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 13 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 12 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 11 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 10 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 9 generations backK081582 Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · Recalled
- 8 generations backK101868 Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010
- 7 generations backK120073 Infx-8000V withToshibamedical Systems Corporation · 2012 · Recalled
- 6 generations backK132106 Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013
- 5 generations backK141541 Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation · 2014
- 4 generations backK142736 XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation · 2015
- 3 generations backK150967 XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation · 2015 · Recalled
- 2 generations backK152785 XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation · 2015 · Recalled
- 1 generation backK172646 XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation · 2017
- This deviceK181415 XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −15 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −14 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −13 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −12 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −11 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −10 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −9 | K081582 | Infx-8000V, Infinix-Cfi and Infinix Vfi | Toshiba America Medical Systems, In.C | 2008 | 1 |
| −8 | K101868 | Infinix-I Interventional Angiography System Model Infx-8000V | Toshiba America Medical Systems, In.C | 2010 | — |
| −7 | K120073 | Infx-8000V with | Toshibamedical Systems Corporation | 2012 | 3 |
| −6 | K132106 | Infinix Angio Workstation W/DTS Software | Toshiba America Medical Systems, In.C | 2013 | — |
| −5 | K141541 | Xidf-AWS801, Angio Workstation, V5.31 | Toshibamedical Systems Corporation | 2014 | — |
| −4 | K142736 | XIDF-AWS801, Angio Workstation, v5.31 | Toshibamedical Systems Corporation | 2015 | — |
| −3 | K150967 | XIDF-AWS801, Angio Workstation, V6.10 | Toshibamedical Systems Corporation | 2015 | 1 |
| −2 | K152785 | XIDF-AWS801, Angio Workstation, V6.20 | Toshibamedical Systems Corporation | 2015 | 1 |
| −1 | K172646 | XIDF-AWS801, Angio Workstation, V7.0 | Toshibamedical Systems Corporation | 2017 | — |
| 0 (this device) | K181415 | XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 | Canon Medical Systems Corporation | 2018 | — |
| +1 | K220342 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 | Canon Medical Systems Corporation | 2022 | — |
| +2 | K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K172646 | XIDF-AWS801, Angio Workstation, V7.0Summary page 5…izing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard]. 13. PREDICATE DEVICE XIDF-AWS801, Angio Workstation, V7.0 (K172646) XIDF-AWS801, Angio Workstation, XIDF-AWS801, Angio Workstation Product… | 2017 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220342 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 | 2022 | 1 |
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 29 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 29 of the 53 ancestors have a recall of any class.
- Of its descendants, K220342 (Canon Medical Systems Corporation, 2022) has gone furthest, with 1 descendant 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?
The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Alphenix series systems, Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging of selective catheter angiography procedures for the whole body (includes heart, chest, abdomen, brain and extremity).
When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used with selective catheter angiography procedures for the heart, chest abdomen, pelvis and brain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181415: XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181415
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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