510(k) · Cleared
Recalled · Class II · 2022Infinix INFX-8000V, V6.40
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba Medical Systems Coroporation · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jun 16, 2017 as substantially equivalent to K162614 (Toshibamedical Systems Corporation, 2016) after an 80-day review. Its family tree reaches back 14 generations to 1989. It has been recalled 5 times.
- Decided
- Jun 16, 2017
- Review
- 80 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 14 generations to K890348 (1989). 31 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 10 generations between
- 3 generations backK143225 INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation · 2015 · Recalled
- 2 generations backK152696 Infx-8000V, V6.20Toshibamedical Systems Corporation · 2016 · Recalled
- 1 generation backK162614 Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation · 2016
- This deviceK170909 Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation · 2017
Show all 14 generations
- Root · 14 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 13 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 12 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 11 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 10 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 9 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 8 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 7 generations backK081582 Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · Recalled
- 6 generations backK101868 Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010
- 5 generations backK120073 Infx-8000V withToshibamedical Systems Corporation · 2012 · Recalled
- 4 generations backK133535 Infx-8000V, V5.30Toshibamedical Systems Corporation · 2014 · Recalled
- 3 generations backK143225 INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation · 2015 · Recalled
- 2 generations backK152696 Infx-8000V, V6.20Toshibamedical Systems Corporation · 2016 · Recalled
- 1 generation backK162614 Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation · 2016
- This deviceK170909 Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −13 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −12 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −11 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −10 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −9 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −8 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −7 | K081582 | Infx-8000V, Infinix-Cfi and Infinix Vfi | Toshiba America Medical Systems, In.C | 2008 | 1 |
| −6 | K101868 | Infinix-I Interventional Angiography System Model Infx-8000V | Toshiba America Medical Systems, In.C | 2010 | — |
| −5 | K120073 | Infx-8000V with | Toshibamedical Systems Corporation | 2012 | 3 |
| −4 | K133535 | Infx-8000V, V5.30 | Toshibamedical Systems Corporation | 2014 | 2 |
| −3 | K143225 | INFX-8000V with Wireless Footswitch | Toshibamedical Systems Corporation | 2015 | 2 |
| −2 | K152696 | Infx-8000V, V6.20 | Toshibamedical Systems Corporation | 2016 | 1 |
| −1 | K162614 | Infinix, INFX-8000V, V6.35 | Toshibamedical Systems Corporation | 2016 | — |
| 0 (this device) | K170909 | Infinix INFX-8000V, V6.40 | Toshiba Medical Systems Coroporation | 2017 | — |
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 |
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 |
|---|---|---|---|
| * | K162614 | Infinix, INFX-8000V, V6.35Summary page 5…e Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard]. 15. PREDICATE DEVICE INFX-8000V, V6.35 (K162614) Product Marketed by 510(k) Number Clearance Date INFX-8000V, V6.35 To… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 31, 2022 | Class II | Z-1666-2022 | Software design | The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy. |
| Feb 5, 2021 | Class II | Z-1174-2021 | Software design | The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles. |
| Dec 8, 2020 | Class II | Z-1269-2021 | Component design/selection | System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. |
| Mar 3, 2020 | Class II | Z-2325-2020 | Process control | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. |
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 21 of the 31 ancestors have a recall of any class.
- 1 other device also cites its predicate K162614.
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. 2017, 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 used 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170909 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170909: Infinix INFX-8000V, V6.40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170909
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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