510(k) · Cleared
Recalled · Class II · 2021Infx-8000F (Infinix Csi and Infinix Dpi)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jun 23, 2008 as substantially equivalent to K052412 (GE Healthcare, 2005) and 1 other predicate after a 13-day review. Its family tree reaches back 6 generations to 1989. 13 later devices descend from it. It has been recalled 8 times.
- Decided
- Jun 23, 2008
- Review
- 13 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 6 generations to K890348 (1989). 18 ancestors in all. 13 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 deviceK081624 Infx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C · 2008
- Descendant · cites it directly · 11 of its ownK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
- Descendant · 2 generations on · 9 of its ownK183013 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
- Descendant · 3 generations on · 8 of its ownK192923 Vitrea Software PackageCanon Medical Systems Corporation · 2020
- Descendant · 4 generations on · 7 of its ownK203312 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021
- Descendant · 5 generations on · 6 of its ownK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018 · cites it directly11descendants
- K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018 · 2 generations on9descendants
- K192923Vitrea Software PackageCanon Medical Systems Corporation · 2020 · 3 generations on8descendants
- K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021 · 4 generations on7descendants
- K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation · 2022 · 5 generations on6descendants
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) | K081624 | Infx-8000F (Infinix Csi and Infinix Dpi) | Toshiba America Medical Systems, In.C | 2008 | — |
| +1 | K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018 | — |
| +2 | K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | — |
| +3 | K192923 | Vitrea Software Package | Canon Medical Systems Corporation | 2020 | — |
| +4 | K203312 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2021 | — |
| +5 | K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software… | Canon Medical Systems Corporation | 2022 | — |
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 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 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] Ik (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? (13)
See all 132 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 |
|---|---|---|---|---|
| Feb 5, 2021 | Class II | Z-1176-2021 | 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-1271-2021 | 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-2327-2020 | Process control | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. |
| Feb 8, 2019 | Class II | Z-0360-2020 | Error in labeling | Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit. |
| Dec 29, 2017 | Class II | Z-0842-2018 | 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. |
| Nov 8, 2012 | Class II | Z-0994-2013 | Software design | Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may… |
| 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… |
| Sep 29, 2008 | Not classified | Z-0005-2009 | Software design | Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation. |
The 5 latest of 8 recalls; the web page lists all.
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, K173088 (Toshibamedical Systems Corporation, 2018) has gone furthest, with 11 descendants of its own.
- 7 other devices also cite its predicate K052412.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
This device is a digital radiography/flucroscopy system used in a diagnostic angiography configuration. This system is indicated for use in diagnostic and angicgraphic 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/K081624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081624: Infx-8000F (Infinix Csi and Infinix Dpi).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081624
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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