510(k) · Cleared
Recalled · Class II · 2017Infx-8000H, Infinix-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 Oct 10, 2008 as substantially equivalent to K081621 (Toshiba America Medical Systems, In.C, 2008) after a 14-day review. Its family tree reaches back 7 generations to 1989. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Oct 10, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 7 generations to K890348 (1989). 19 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 6 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 5 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 4 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 3 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 2 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 1 generation backK081621 Infx-8000C (Infinix CC-I and VC-I)Toshiba America Medical Systems, In.C · 2008 · Recalled
- This deviceK082830 Infx-8000H, Infinix-IToshiba America Medical Systems, In.C · 2008
- Descendant · cites it directly · 0 of its ownK182546 Alphenix, INFX-8000H/B, V8.0Canon Medical Systems Corporation · 2018 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K182546Alphenix, INFX-8000H/B, V8.0Canon Medical Systems Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −6 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −5 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −4 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −3 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −2 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −1 | K081621 | Infx-8000C (Infinix CC-I and VC-I) | Toshiba America Medical Systems, In.C | 2008 | 1 |
| 0 (this device) | K082830 | Infx-8000H, Infinix-I | Toshiba America Medical Systems, In.C | 2008 | — |
| +1 | K182546 | Alphenix, INFX-8000H/B, V8.0 | Canon Medical Systems Corporation | 2018 | 2 |
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 |
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? (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 |
|---|---|---|---|
| * | K081621 | Infx-8000C (Infinix CC-I and VC-I)Summary page 1…x-ray System) [Fed. Reg. No. 892.1650, Pro. Code: 90MQB} Il (per 21 CFR 892.1650) 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard Toshiba INFX-8000C [k081621] Addition of new x-ray table and model change This system is a single system that employs X-rays to obtain fluoroscopy or radio… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182546 | Alphenix, INFX-8000H/B, V8.0 | 2018 | 0 |
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-0845-2018 | 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. |
| 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 1.6 years on median.
- 15 of the 19 ancestors have a recall of any class.
- Of its descendants, K182546 (Canon Medical Systems Corporation, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K081621.
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 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/K082830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082830: Infx-8000H, Infinix-I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082830
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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