510(k) · Cleared
ClearedInfinix-I Interventional Angiography System Model Infx-8000V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · OWB Interventional Fluoroscopic X-Ray System
Cleared on Sep 7, 2010 as substantially equivalent to K081582 (Toshiba America Medical Systems, In.C, 2008) and 2 other predicates after a 67-day review. Its family tree reaches back 8 generations to 1989. 21 later devices descend from it.
- Decided
- Sep 7, 2010
- Review
- 67 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K890348 (1989). 25 ancestors in all. 21 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 7 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 6 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 5 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 4 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 3 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 2 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 1 generation backK081582 Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · Recalled
- This deviceK101868 Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010
- Descendant · cites it directly · 20 of its ownK120073 Infx-8000V withToshibamedical Systems Corporation · 2012 · Recalled
- Descendant · 2 generations on · 10 of its ownK133535 Infx-8000V, V5.30Toshibamedical Systems Corporation · 2014 · Recalled
- Descendant · 3 generations on · 9 of its ownK143225 INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation · 2015 · Recalled
- Descendant · 4 generations on · 8 of its ownK152696 Infx-8000V, V6.20Toshibamedical Systems Corporation · 2016 · Recalled
- Descendant · 2 generations on · 8 of its ownK132106 Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K120073Infx-8000V withToshibamedical Systems Corporation · 2012 · cites it directly20descendants
- K133535Infx-8000V, V5.30Toshibamedical Systems Corporation · 2014 · 2 generations on10descendants
- K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation · 2015 · 3 generations on9descendants
- K152696Infx-8000V, V6.20Toshibamedical Systems Corporation · 2016 · 4 generations on8descendants
- K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −7 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −6 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −5 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −4 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −3 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −2 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −1 | K081582 | Infx-8000V, Infinix-Cfi and Infinix Vfi | Toshiba America Medical Systems, In.C | 2008 | 1 |
| 0 (this device) | 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 |
| +2 | K133535 | Infx-8000V, V5.30 | Toshibamedical Systems Corporation | 2014 | 2 |
| +3 | K143225 | INFX-8000V with Wireless Footswitch | Toshibamedical Systems Corporation | 2015 | 2 |
| +4 | K152696 | Infx-8000V, V6.20 | Toshibamedical Systems Corporation | 2016 | 1 |
| +2 | K132106 | Infinix Angio Workstation W/DTS Software | Toshiba America Medical Systems, In.C | 2013 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K081582 | Infx-8000V, Infinix-Cfi and Infinix Vfi Our OCR of the scanned summary read K081852, FDA’s number for Truly Automatic Blood Pressure Monitor, Model DB11 (Truly Instrument Limited). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Toshiba, INFX-8000V”. | 2008 |
| * | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ Our OCR of the scanned summary read K054212, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “GE, Innova 2100, 3100, 4400 w/Innova 3D or InnovaSpin”. | 2005 |
| * | K011447 | IN Space 3DSummary page 2…omparable type and substantially equivalent to: Toshiba, INFX-8000V; K081852 GE, Innova 2100, 3100, 4400 w/Innova 3D or InnovaSpin; K054212 Siemens, In Space 3D Option; K011447 Therefore the INFX-8000V complies with the same or equivalent standards and has the same intended use as the predicate devices.… | 2001 |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120073 | Infx-8000V with | 2012 | 20 |
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 21 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 17 of the 25 ancestors have a recall of any class.
- Of its descendants, K120073 (Toshibamedical Systems Corporation, 2012) has gone furthest, with 20 descendants of its own.
- 1 other device also cites its predicate K081582.
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. 2010, 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 angiography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
3D Road-mapping function to assist in the planning and execution of interventional procedures
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/K101868 · printed Nov 5, 2026
Cite this page
510(k) Report. “K101868: Infinix-I Interventional Angiography System Model Infx-8000V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101868
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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