# K152696: Infx-8000V, V6.20

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jan 12, 2016 after 113 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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: 12 generations back to K890348 (1989). 29 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143225: INFX-8000V with Wireless Footswitch, Toshibamedical Systems Corporation (2015) Summary page 5.

## Most influential descendants
- K162614: Infinix, INFX-8000V, V6.35 (2016), 7 descendants of its own
- K172863: Infinix-i, INFX-8000V, V7.0 (2017), 5 descendants of its own
- K181670: Alphenix, INFX-8000V/B, V8.0 (2018), 4 descendants of its own
- K203551: Alphenix, INFX-8000V/B, /S, V9.1 (2020), 3 descendants of its own
- K233107: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 (2024), 2 descendants of its own

## Recalls of this device
- Aug 14, 2015 · Class II · Z-0752-2016: When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently,

## 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/K152696
Methodology: https://510kreport.com/methodology