510(k) · Cleared
Recalled · Class II · 2021Infx-8000C, V6.20
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 Jan 15, 2016 as substantially equivalent to K113052 (Toshiba America Medical Systems, In.C, 2011) after a 116-day review. Its family tree reaches back 8 generations to 1989. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Jan 15, 2016
- Review
- 116 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 8 generations to K890348 (1989). 20 ancestors in all. 3 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 backK081621 Infx-8000C (Infinix CC-I and VC-I)Toshiba America Medical Systems, In.C · 2008 · Recalled
- 1 generation backK113052 Infinix-CciToshiba America Medical Systems, In.C · 2011 · Recalled
- This deviceK152697 Infx-8000C, V6.20Toshibamedical Systems Corporation · 2016
- Descendant · cites it directly · 2 of its ownK181804 Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK210900 Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation · 2021 · Recalled
- Descendant · 3 generations on · 0 of its ownK251645 Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B…Canon Medical Systems Corporation · 2025
Most influential descendants
Showing 3 of 3 · See all- K181804Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation · 2018 · cites it directly2descendants
- K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation · 2021 · 2 generations on1descendant
- K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation · 2025 · 3 generations on0descendants
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 | K081621 | Infx-8000C (Infinix CC-I and VC-I) | Toshiba America Medical Systems, In.C | 2008 | 1 |
| −1 | K113052 | Infinix-Cci | Toshiba America Medical Systems, In.C | 2011 | 1 |
| 0 (this device) | K152697 | Infx-8000C, V6.20 | Toshibamedical Systems Corporation | 2016 | — |
| +1 | K181804 | Alphenix, INFX-8000C/B, V8.0 | Canon Medical Systems Corporation | 2018 | 3 |
| +2 | K210900 | Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 | Canon Medical Systems Corporation | 2021 | 7 |
| +3 | K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B… | Canon Medical Systems Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K113052 | Infinix-CciSummary page 5…ing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard]. 11. PREDICATE DEVICE: INFX-8000C, w/Spot Fluoroscopy Option (K113052) TABLE 1: Predicate Device Product Marketed by 510(k) Number Clearance Date… | 2011 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181804 | Alphenix, INFX-8000C/B, V8.0 | 2018 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 5, 2021 | Class II | Z-1175-2021 | 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-1270-2021 | 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. |
| Oct 8, 2020 | Class II | Z-0532-2021 | Component design/selection | There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result in a delay with procedure and/or potential damage… |
| Mar 3, 2020 | Class II | Z-2326-2020 | 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-0843-2018 | 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 27 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 16 of the 20 ancestors have a recall of any class.
- Of its descendants, K181804 (Canon Medical Systems Corporation, 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K113052.
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. 2016, 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 and 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/K152697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152697: Infx-8000C, V6.20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152697
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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