# K113052: Infinix-Cci

- Pathway: 510(k) (Special)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Nov 22, 2011 after 40 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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). 19 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081621: Infx-8000C (Infinix CC-I and VC-I), Toshiba America Medical Systems, In.C (2008) Summary page 1.

## Most influential descendants
- K152697: Infx-8000C, V6.20 (2016), 3 descendants of its own
- K134025: Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CT (2014), 3 descendants of its own
- K181804: Alphenix, INFX-8000C/B, V8.0 (2018), 2 descendants of its own
- K143223: CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT (2015), 2 descendants of its own
- K210900: Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 (2021), 1 descendant of its own

## Recalls of this device
- 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 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/K113052
Methodology: https://510kreport.com/methodology