510(k) · Cleared
ClearedInfinix Angio Workstation W/DTS Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Nov 12, 2013 as substantially equivalent to K123097 (Toshiba America Medical Systems, In.C, 2013) and 1 other predicate after a 127-day review. Its family tree reaches back 10 generations to 1989. 8 later devices descend from it.
- Decided
- Nov 12, 2013
- Review
- 127 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K890348 (1989). 30 ancestors in all, the oldest K853753 (1985). 8 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 6 generations between
- 3 generations backK081582 Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · Recalled
- 2 generations backK101868 Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010
- 1 generation backK120073 Infx-8000V withToshibamedical Systems Corporation · 2012 · Recalled
- This deviceK132106 Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013
- Descendant · cites it directly · 7 of its ownK141541 Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation · 2014
- Descendant · 2 generations on · 6 of its ownK142736 XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation · 2015
- Descendant · 3 generations on · 5 of its ownK150967 XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation · 2015 · Recalled
- Descendant · 4 generations on · 4 of its ownK152785 XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation · 2015 · Recalled
- Descendant · 5 generations on · 3 of its ownK172646 XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation · 2017
Show all 10 generations
- Root · 10 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 9 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 8 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 7 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 6 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 5 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 4 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 3 generations backK081582 Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · Recalled
- 2 generations backK101868 Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010
- 1 generation backK120073 Infx-8000V withToshibamedical Systems Corporation · 2012 · Recalled
- This deviceK132106 Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation · 2014 · cites it directly7descendants
- K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation · 2015 · 2 generations on6descendants
- K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation · 2015 · 3 generations on5descendants
- K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation · 2015 · 4 generations on4descendants
- K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation · 2017 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −9 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −8 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −7 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −6 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −5 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −4 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −3 | K081582 | Infx-8000V, Infinix-Cfi and Infinix Vfi | Toshiba America Medical Systems, In.C | 2008 | 1 |
| −2 | K101868 | Infinix-I Interventional Angiography System Model Infx-8000V | Toshiba America Medical Systems, In.C | 2010 | — |
| −1 | K120073 | Infx-8000V with | Toshibamedical Systems Corporation | 2012 | 3 |
| 0 (this device) | K132106 | Infinix Angio Workstation W/DTS Software | Toshiba America Medical Systems, In.C | 2013 | — |
| +1 | K141541 | Xidf-AWS801, Angio Workstation, V5.31 | Toshibamedical Systems Corporation | 2014 | — |
| +2 | K142736 | XIDF-AWS801, Angio Workstation, v5.31 | Toshibamedical Systems Corporation | 2015 | — |
| +3 | 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 |
| +5 | K172646 | XIDF-AWS801, Angio Workstation, V7.0 | Toshibamedical Systems Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 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 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? (2)
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 |
|---|---|---|---|
| * | K123097 | Dose Tracking System Model Xidf-DTS801Summary page 1…e-intensified 10. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard 11. PREDICATE DEVICE: Toshiba Dose Tracking Software - K123097 Toshiba XIDF-AWS801 Angio Workstation - K1 20073 12. REASON FOR SUBMISSION: Modification of a cleared device === Page 2… | 2013 |
| * | K120073 | Infx-8000V withSummary page 1…Subchapter J, Federal Diagnostic X-ray Equipment Standard 11. PREDICATE DEVICE: Toshiba Dose Tracking Software - K123097 Toshiba XIDF-AWS801 Angio Workstation - K1 20073 12. REASON FOR SUBMISSION: Modification of a cleared device… | 2012 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141541 | Xidf-AWS801, Angio Workstation, V5.31 | 2014 | 7 |
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 24 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 18 of the 30 ancestors have a recall of any class.
- Of its descendants, K141541 (Toshibamedical Systems Corporation, 2014) has gone furthest, with 7 descendants of its own.
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. 2013, 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 is used in combination with an interventional angiography system (Infinix-i series systems and INFX-8000V and INFX-8000C systems) to provide 2D and 3D imaging and Dose Tracking System functions in selective catheter angiography for the heart, chest, and abdomen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132106: Infinix Angio Workstation W/DTS Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132106
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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