# K081621: Infx-8000C (Infinix CC-I and VC-I)

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jun 23, 2008 after 14 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- 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: 6 generations back to K890348 (1989). 18 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052412: Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ, GE Healthcare (2005) Summary page 1.
- K052884: Model DFP-8000D/FPD Digital Radiography System with Flat Panel Detector, Toshiba America Medical Systems, In.C (2005) Summary page 1.

## Most influential descendants
- K113052: Infinix-Cci (2011), 7 descendants of its own
- 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

## Recalls of this device
- Oct 3, 2011 · Not classified · Z-0331-2012: The recall was initiated because Toshiba has confirmed that during patient transfer from a gurney to the catherization table, the tabletop may rotate unexpectedly when sufficient force is applied to t

## 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 bloecd vessels in the heart, brain, abdomen and lower extremities.

Source page: https://510kreport.com/device/K081621
Methodology: https://510kreport.com/methodology