# K082830: Infx-8000H, Infinix-I

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Oct 10, 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: 2 (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.
1 later device descends from it; 1 cites it directly.
0 of 21 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
- K182546: Alphenix, INFX-8000H/B, V8.0 (2018), 0 descendants of its own

## Recalls of this device
- Dec 29, 2017 · Class II · Z-0845-2018: 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.
- 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 blood vessels in the heart, brain, abdomen and lower extremities.

Source page: https://510kreport.com/device/K082830
Methodology: https://510kreport.com/methodology