# K061976: Ckis-004A Injector Synchronization Option

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Sep 27, 2006 after 76 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K934086 (1995). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043087: Somatom Care Contrast CT, Siemens Medical Solutions USA, Inc. (2004). Our reading of the summary gave K043807, 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, “Siemens Care Contrast CT”.
- K033881: Medrad Stellant CT Injector System with Imaging System Interface Module, Medrad, Inc. (2004) Summary page 1.

## Most influential descendants
- K082960: GE Xtreme Injector Option (2008), 0 descendants of its own

## Indications for use
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy The CKIS-004A, Injector Synchronization Option is intended to facilitate contrast enhanced CT examinations by interfacing the CT system to a contrast injection system. When employed, the CKIS-004A will allow both the CT scan and the contrast bolus to occur by activation of either the CT or the injector. The communications between the devices is based upon the CiA-425 standard.

Source page: https://510kreport.com/device/K061976
Methodology: https://510kreport.com/methodology