# K082960: GE Xtreme Injector Option

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Oct 17, 2008 after 14 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K934086 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061976: Ckis-004A Injector Synchronization Option, Toshiba America Medical Systems, In.C (2006) Summary page 1.
- K043087: Somatom Care Contrast CT, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.

## Indications for use
The GE Xtream Injector Option is designed to facilitate contrast-enhanced Computed Tomography (CT) by providing a method for connection and communication to the CT system with a compatible injector. When used, it allows the user to synchronize the start of the CT scan and the injector by pressing one single start button at the CT scanner. The GE Xtream Injector Option is based on the protocol contained in the CIA425 standard, and allows approved injectors to operate with certain GE Healthcare CT scanners that have the modified software and hardware interface required for the CIA425 communication protocol. This device is only the communication protocol and bus interface needed to communicate with a 510(k) cleared Injector that is compatible with the CIA425 standard.

Source page: https://510kreport.com/device/K082960
Methodology: https://510kreport.com/methodology