# K120073: Infx-8000V with

- Pathway: 510(k) (Special)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jan 26, 2012 after 16 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K890348 (1989). 26 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101868: Infinix-I Interventional Angiography System Model Infx-8000V, Toshiba America Medical Systems, In.C (2010) Summary page 1.

## Most influential descendants
- 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
- K132106: Infinix Angio Workstation W/DTS Software (2013), 8 descendants of its own
- K162614: Infinix, INFX-8000V, V6.35 (2016), 7 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,
- May 12, 2014 · Class II · Z-1714-2014: Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, th
- Nov 8, 2012 · Class II · Z-0994-2013: Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed o

## 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/K120073
Methodology: https://510kreport.com/methodology