510(k) · Cleared
Recalled · 2011Infx-8000C (Infinix CC-I and VC-I)
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 Jun 23, 2008 as substantially equivalent to K052412 (GE Healthcare, 2005) and 1 other predicate after a 14-day review. Its family tree reaches back 6 generations to 1989. 10 later devices descend from it. It has been recalled once.
- Decided
- Jun 23, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K890348 (1989). 18 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 5 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 4 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 3 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 2 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 1 generation backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- This deviceK081621 Infx-8000C (Infinix CC-I and VC-I)Toshiba America Medical Systems, In.C · 2008
- Descendant · cites it directly · 7 of its ownK113052 Infinix-CciToshiba America Medical Systems, In.C · 2011 · Recalled
- Descendant · 2 generations on · 3 of its ownK152697 Infx-8000C, V6.20Toshibamedical Systems Corporation · 2016 · Recalled
- Descendant · 2 generations on · 3 of its ownK134025 Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation · 2014
- Descendant · 3 generations on · 2 of its ownK181804 Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation · 2018 · Recalled
- Descendant · 2 generations on · 2 of its ownK143223 CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K113052Infinix-CciToshiba America Medical Systems, In.C · 2011 · cites it directly7descendants
- K152697Infx-8000C, V6.20Toshibamedical Systems Corporation · 2016 · 2 generations on3descendants
- K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation · 2014 · 2 generations on3descendants
- K181804Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation · 2018 · 3 generations on2descendants
- K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation · 2015 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −5 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −4 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −3 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −2 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −1 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| 0 (this device) | K081621 | Infx-8000C (Infinix CC-I and VC-I) | Toshiba America Medical Systems, In.C | 2008 | — |
| +1 | K113052 | Infinix-Cci | Toshiba America Medical Systems, In.C | 2011 | 1 |
| +2 | K152697 | Infx-8000C, V6.20 | Toshibamedical Systems Corporation | 2016 | 5 |
| +2 | K134025 | Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CT | Toshibamedical Systems Corporation | 2014 | — |
| +3 | K181804 | Alphenix, INFX-8000C/B, V8.0 | Canon Medical Systems Corporation | 2018 | 3 |
| +2 | K143223 | CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT | Toshibamedical Systems Corporation | 2015 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 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 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 |
|---|---|---|---|
| * | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQSummary page 1…[Fed. Reg. No. 892.1650, Pro. Code: 90MQB] Il (per 21 CFR 892.1650) 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard GE Innova 4100; 510(k) Control # k052412 Toshiba DFP-8000D/FPD; 510(k) Control # K052884 Model Number Change These systems are single or dual plane systems that employ… | 2005 |
| * | K052884 | Model DFP-8000D/FPD Digital Radiography System with Flat Panel DetectorSummary page 1…(per 21 CFR 892.1650) 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard GE Innova 4100; 510(k) Control # k052412 Toshiba DFP-8000D/FPD; 510(k) Control # K052884 Model Number Change These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography imag… | 2005 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 3, 2011 | Not classified | Z-0331-2012 | Device Design | The recall was initiated because Toshiba has confirmed that during patient transfer from a gurney to the catherization table, the tabletop may rotate unexpectedly when sufficient force is applied to the tabletop. The result of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 14 of the 18 ancestors have a recall of any class.
- Of its descendants, K113052 (Toshiba America Medical Systems, In.C, 2011) has gone furthest, with 7 descendants of its own.
- 7 other devices also cite its predicate K052412.
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. 2008, 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?
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 bloecd 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/K081621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081621: Infx-8000C (Infinix CC-I and VC-I).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081621
Report an extraction error
Are you the manufacturer?
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