# K152697: Infx-8000C, V6.20

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jan 15, 2016 after 116 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K890348 (1989). 20 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113052: Infinix-Cci, Toshiba America Medical Systems, In.C (2011) Summary page 5.

## Most influential descendants
- K181804: Alphenix, INFX-8000C/B, V8.0 (2018), 2 descendants of its own
- K210900: Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 (2021), 1 descendant of its own
- K251645: Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP (2025), 0 descendants of its own

## Recalls of this device
- Feb 5, 2021 · Class II · Z-1175-2021: 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-1270-2021: 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: 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 w
- Mar 3, 2020 · Class II · Z-2326-2020: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K152697
Methodology: https://510kreport.com/methodology