# K133535: Infx-8000V, V5.30

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jul 23, 2014 after 247 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K890348 (1989). 27 ancestors in all.
10 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)
- K120073: Infx-8000V with, Toshibamedical Systems Corporation (2012) Summary page 1.

## Most influential descendants
- K143225: INFX-8000V with Wireless Footswitch (2015), 9 descendants of its own
- K152696: Infx-8000V, V6.20 (2016), 8 descendants of its own
- 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

## Recalls of this device
- 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.
- 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 use 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/K133535
Methodology: https://510kreport.com/methodology