# K112054: Infinix CF-I/SP and Infinix VF-I/SP Model Infx-8000V

- Pathway: 510(k) (Special)
- Applicant: Toshiba Medical Systems Corporation, Japan
- Decided: Aug 5, 2011 after 17 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K890348 (1989). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081582: Infx-8000V, Infinix-Cfi and Infinix Vfi, Toshiba America Medical Systems, In.C (2008) Summary page 2.

## 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 angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Source page: https://510kreport.com/device/K112054
Methodology: https://510kreport.com/methodology