510(k) · Cleared
ClearedXIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Medical Systems Corporation · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Sep 12, 2023 as substantially equivalent to K220342 (Canon Medical Systems Corporation, 2022) after a 22-day review. Its family tree reaches back 18 generations to 1989.
- Decided
- Sep 12, 2023
- Review
- 22 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K890348 (1989). 55 ancestors in all, the oldest K853753 (1985). No later device cites it as a predicate yet.
- Root · 18 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 14 generations between
- 3 generations backK172646 XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation · 2017
- 2 generations backK181415 XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation · 2018
- 1 generation backK220342 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation · 2022
- This deviceK232526 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation · 2023
Show all 18 generations
- Root · 18 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 17 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 16 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 15 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 14 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 13 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 12 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 11 generations backK081582 Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · Recalled
- 10 generations backK101868 Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010
- 9 generations backK120073 Infx-8000V withToshibamedical Systems Corporation · 2012 · Recalled
- 8 generations backK132106 Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013
- 7 generations backK141541 Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation · 2014
- 6 generations backK142736 XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation · 2015
- 5 generations backK150967 XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation · 2015 · Recalled
- 4 generations backK152785 XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation · 2015 · Recalled
- 3 generations backK172646 XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation · 2017
- 2 generations backK181415 XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation · 2018
- 1 generation backK220342 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation · 2022
- This deviceK232526 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −17 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −16 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −15 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −14 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −13 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −12 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −11 | K081582 | Infx-8000V, Infinix-Cfi and Infinix Vfi | Toshiba America Medical Systems, In.C | 2008 | 1 |
| −10 | K101868 | Infinix-I Interventional Angiography System Model Infx-8000V | Toshiba America Medical Systems, In.C | 2010 | — |
| −9 | K120073 | Infx-8000V with | Toshibamedical Systems Corporation | 2012 | 3 |
| −8 | K132106 | Infinix Angio Workstation W/DTS Software | Toshiba America Medical Systems, In.C | 2013 | — |
| −7 | K141541 | Xidf-AWS801, Angio Workstation, V5.31 | Toshibamedical Systems Corporation | 2014 | — |
| −6 | K142736 | XIDF-AWS801, Angio Workstation, v5.31 | Toshibamedical Systems Corporation | 2015 | — |
| −5 | K150967 | XIDF-AWS801, Angio Workstation, V6.10 | Toshibamedical Systems Corporation | 2015 | 1 |
| −4 | K152785 | XIDF-AWS801, Angio Workstation, V6.20 | Toshibamedical Systems Corporation | 2015 | 1 |
| −3 | K172646 | XIDF-AWS801, Angio Workstation, V7.0 | Toshibamedical Systems Corporation | 2017 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 JAA? 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 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 |
|---|---|---|---|
| * | K220342 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Summary page 5…g Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard]. 14. PREDICATE DEVICE XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 (K220342) TABLE 1: Predicate Device XIDF-AWS801, Angio Workstation (Alphenix Trade Proprieta… | 2022 |
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 34 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 29 of the 55 ancestors have a recall of any class.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
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/K232526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232526: XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232526
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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