# K081624: Infx-8000F (Infinix Csi and Infinix Dpi)

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jun 23, 2008 after 13 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K890348 (1989). 18 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052412: Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ, GE Healthcare (2005) Summary page 1.
- K052884: Model DFP-8000D/FPD Digital Radiography System with Flat Panel Detector, Toshiba America Medical Systems, In.C (2005) Summary page 1.

## Most influential descendants
- K173088: Vitrea Software Toshiba Package VSTP-001A (2018), 11 descendants of its own
- K183013: Vitrea Software Package, VSTP-001A (2018), 9 descendants of its own
- K192923: Vitrea Software Package (2020), 8 descendants of its own
- K203312: Vitrea Software Package, VSTP-001A (2021), 7 descendants of its own
- K213504: Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A (2022), 6 descendants of its own

## Recalls of this device
- Feb 5, 2021 · Class II · Z-1176-2021: 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: 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: 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: 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: 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: 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 o
- Oct 3, 2011 · Not classified · Z-0331-2012: 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 t
- Sep 29, 2008 · Not classified · Z-0005-2009: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K081624
Methodology: https://510kreport.com/methodology