# K101868: Infinix-I Interventional Angiography System Model Infx-8000V

- Pathway: 510(k) (Special)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Sep 7, 2010 after 67 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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). 25 ancestors in all.
21 later devices descend from it; 1 cites 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)
- K081582: Infx-8000V, Infinix-Cfi and Infinix Vfi, Toshiba America Medical Systems, In.C (2008). Our OCR of the scanned summary read K081852, FDA’s number for Truly Automatic Blood Pressure Monitor, Model DB11 (Truly Instrument Limited). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Toshiba, INFX-8000V”.
- K052412: Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ, GE Healthcare (2005). Our OCR of the scanned summary read K054212, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “GE, Innova 2100, 3100, 4400 w/Innova 3D or InnovaSpin”.
- K011447: IN Space 3D, Siemens Medical Solutions USA, Inc. (2001) Summary page 2.

## Most influential descendants
- 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
- K132106: Infinix Angio Workstation W/DTS Software (2013), 8 descendants of its own

## 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. 3D Road-mapping function to assist in the planning and execution of interventional procedures

Source page: https://510kreport.com/device/K101868
Methodology: https://510kreport.com/methodology