510(k) · Cleared
Recalled · Class II · 2017Infx-8000V, V5.30
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 Jul 23, 2014 as substantially equivalent to K120073 (Toshibamedical Systems Corporation, 2012) after a 247-day review. Its family tree reaches back 10 generations to 1989. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 23, 2014
- Review
- 247 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 10 generations to K890348 (1989). 27 ancestors in all. 10 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 deviceK133535 Infx-8000V, V5.30Toshibamedical Systems Corporation · 2014
- Descendant · cites it directly · 9 of its ownK143225 INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation · 2015 · Recalled
- Descendant · 2 generations on · 8 of its ownK152696 Infx-8000V, V6.20Toshibamedical Systems Corporation · 2016 · Recalled
- Descendant · 3 generations on · 7 of its ownK162614 Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation · 2016
- Descendant · 4 generations on · 5 of its ownK172863 Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation · 2017
- Descendant · 5 generations on · 4 of its ownK181670 Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation · 2018 · Recalled
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 deviceK133535 Infx-8000V, V5.30Toshibamedical Systems Corporation · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation · 2015 · cites it directly9descendants
- K152696Infx-8000V, V6.20Toshibamedical Systems Corporation · 2016 · 2 generations on8descendants
- K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation · 2016 · 3 generations on7descendants
- K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation · 2017 · 4 generations on5descendants
- K181670Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation · 2018 · 5 generations on4descendants
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) | K133535 | Infx-8000V, V5.30 | Toshibamedical Systems Corporation | 2014 | — |
| +1 | K143225 | INFX-8000V with Wireless Footswitch | Toshibamedical Systems Corporation | 2015 | 2 |
| +2 | K152696 | Infx-8000V, V6.20 | Toshibamedical Systems Corporation | 2016 | 1 |
| +3 | K162614 | Infinix, INFX-8000V, V6.35 | Toshibamedical Systems Corporation | 2016 | — |
| +4 | K172863 | Infinix-i, INFX-8000V, V7.0 | Toshibamedical Systems Corporation | 2017 | — |
| +5 | K181670 | Alphenix, INFX-8000V/B, V8.0 | Canon Medical Systems Corporation | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K120073 | Infx-8000V withSummary page 1…November 15, 2013 6. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard 7. PREDICATE DEVICE: INFX-8000V w/ 3D Roadmapping (K1 20073) Page 1 of 3… | 2012 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143225 | INFX-8000V with Wireless Footswitch | 2015 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 29, 2017 | Class II | Z-0844-2018 | Process control | During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error. |
| Aug 14, 2015 | Class II | Z-0752-2016 | Radiation Control for Health and Safety Act | When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 18 of the 27 ancestors have a recall of any class.
- Of its descendants, K143225 (Toshibamedical Systems Corporation, 2015) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K120073.
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. 2014, 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 use in a diagnostic 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/K133535 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133535: Infx-8000V, V5.30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133535
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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