# K081582: Infx-8000V, Infinix-Cfi and Infinix Vfi

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jun 17, 2008 after 12 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K890348 (1989). 20 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060259: Digital Fluoroscopic Imaging Systems - Innova  3131 & Innova 2121, Ge Medical Systems, LLC (2006) 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
- K101868: Infinix-I Interventional Angiography System Model Infx-8000V (2010), 21 descendants of its own
- K120073: Infx-8000V with (2012), 20 descendants of its own
- K133535: Infx-8000V, V5.30 (2014), 10 descendants of its own
- K143225: INFX-8000V with Wireless Footswitch (2015), 9 descendants of its own
- K152696: Infx-8000V, V6.20 (2016), 8 descendants of its own

## Recalls of this device
- 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

## Indications for use
This device is a digital radiography/fluoroscopy 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/K081582
Methodology: https://510kreport.com/methodology