# K063090: Medrad Stellant CT Injector System with XDS Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Mar 27, 2007 after 168 days
- Product code: IZQ (Injector, Contrast Medium, Automatic)
- 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). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033881: Medrad Stellant CT Injector System with Imaging System Interface Module, Medrad, Inc. (2004) Summary page 1.

## Most influential descendants
- K173773: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT (2018), 4 descendants of its own
- K182273: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT (2018), 3 descendants of its own
- K210541: ulrichINJECT CT motion (2021), 1 descendant of its own
- K251295: ulrichINJECT CT Motion (XD 8000) (2025), 0 descendants of its own
- K192370: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation (2019), 0 descendants of its own

## Indications for use
The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. The MEDRAD Extravasation Detection System (XDS) accessory is designed to aid in the detection of intravenous contrast media from the injection site into the surrounding tissue during diagnostic studies in computed tomography (CT) applications.

Source page: https://510kreport.com/device/K063090
Methodology: https://510kreport.com/methodology