# K170909: Infinix INFX-8000V, V6.40

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba Medical Systems Coroporation
- Decided: Jun 16, 2017 after 80 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: 14 generations back to K890348 (1989). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162614: Infinix, INFX-8000V, V6.35, Toshibamedical Systems Corporation (2016) Summary page 5.

## Recalls of this device
- Jan 31, 2022 · Class II · Z-1666-2022: The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
- Feb 5, 2021 · Class II · Z-1174-2021: 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-1269-2021: 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-2325-2020: 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-0844-2018: 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 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/K170909
Methodology: https://510kreport.com/methodology