510(k) · Cleared
Recalled · Class II · 2016XIDF-AWS801, Angio Workstation, V6.10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshibamedical Systems Corporation · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jun 18, 2015 as substantially equivalent to K142736 (Toshibamedical Systems Corporation, 2015) after a 66-day review. Its family tree reaches back 13 generations to 1989. 5 later devices descend from it. It has been recalled once.
- Decided
- Jun 18, 2015
- Review
- 66 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 13 generations to K890348 (1989). 50 ancestors in all, the oldest K853753 (1985). 5 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 9 generations between
- 3 generations backK132106 Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013
- 2 generations backK141541 Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation · 2014
- 1 generation backK142736 XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation · 2015
- This deviceK150967 XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation · 2015
- Descendant · cites it directly · 4 of its ownK152785 XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation · 2015 · Recalled
- Descendant · 2 generations on · 3 of its ownK172646 XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation · 2017
- Descendant · 3 generations on · 2 of its ownK181415 XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation · 2018
- Descendant · 4 generations on · 1 of its ownK220342 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation · 2022
- Descendant · 5 generations on · 0 of its ownK232526 XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation · 2023
Show all 13 generations
- Root · 13 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 12 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 11 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 10 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 9 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 8 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 7 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 6 generations backK081582 Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · Recalled
- 5 generations backK101868 Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010
- 4 generations backK120073 Infx-8000V withToshibamedical Systems Corporation · 2012 · Recalled
- 3 generations backK132106 Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013
- 2 generations backK141541 Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation · 2014
- 1 generation backK142736 XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation · 2015
- This deviceK150967 XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation · 2015
Most influential descendants
Showing 5 of 5 · See all- K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation · 2015 · cites it directly4descendants
- K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation · 2017 · 2 generations on3descendants
- K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation · 2018 · 3 generations on2descendants
- K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation · 2022 · 4 generations on1descendant
- K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −12 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −11 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −10 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −9 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −8 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −7 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −6 | K081582 | Infx-8000V, Infinix-Cfi and Infinix Vfi | Toshiba America Medical Systems, In.C | 2008 | 1 |
| −5 | K101868 | Infinix-I Interventional Angiography System Model Infx-8000V | Toshiba America Medical Systems, In.C | 2010 | — |
| −4 | K120073 | Infx-8000V with | Toshibamedical Systems Corporation | 2012 | 3 |
| −3 | K132106 | Infinix Angio Workstation W/DTS Software | Toshiba America Medical Systems, In.C | 2013 | — |
| −2 | K141541 | Xidf-AWS801, Angio Workstation, V5.31 | Toshibamedical Systems Corporation | 2014 | — |
| −1 | K142736 | XIDF-AWS801, Angio Workstation, v5.31 | Toshibamedical Systems Corporation | 2015 | — |
| 0 (this device) | K150967 | XIDF-AWS801, Angio Workstation, V6.10 | Toshibamedical Systems Corporation | 2015 | — |
| +1 | K152785 | XIDF-AWS801, Angio Workstation, V6.20 | Toshibamedical Systems Corporation | 2015 | 1 |
| +2 | K172646 | XIDF-AWS801, Angio Workstation, V7.0 | Toshibamedical Systems Corporation | 2017 | — |
| +3 | K181415 | XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 | Canon Medical Systems Corporation | 2018 | — |
| +4 | K220342 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 | Canon Medical Systems Corporation | 2022 | — |
| +5 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K142736 | XIDF-AWS801, Angio Workstation, v5.31Summary page 5…pment Standard 7. PRODUCT CODE: The Primary Product Code is OWB and the Secondary Product Code is JAA 8. PREDICATE DEVICE: XIDF-AWS801, Angio Workstation, V5.31 (K142736) 9. REASON FOR SUBMISSION: Modification of a cleared device 10. SUBMISSION TYPE: Traditional 510(k) 11. DEVICE DESCRIPT… | 2015 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152785 | XIDF-AWS801, Angio Workstation, V6.20 | 2015 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 24, 2016 | Class II | Z-2188-2016 | Radiation Control for Health and Safety Act | During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 27 of the 50 ancestors have a recall of any class.
- Of its descendants, K152785 (Toshibamedical Systems Corporation, 2015) has gone furthest, with 4 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. 2015, 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 (Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging in 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 in 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/K150967 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150967: XIDF-AWS801, Angio Workstation, V6.10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150967
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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