# K033881: Medrad Stellant CT Injector System with Imaging System Interface Module

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Mar 2, 2004 after 78 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- 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: 3 generations back to K934086 (1995). 3 ancestors in all.
34 later devices descend from it; 5 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023183: Medrad Stellant CT Injector System, Medrad, Inc. (2003) Summary page 1.

## Most influential descendants
- K051799: Disposable CT/MR Syringes for Nemoto Injectors (2005), 18 descendants of its own
- K072696: Ant Angiographic Syringes, Model (S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 (2008), 15 descendants of its own
- K151960: Sterile High-pressure Angiographic Syringes for Single-use (2016), 8 descendants of its own
- K072886: Medrad Stellant CT Injector System with P3T (2007), 7 descendants of its own
- K063090: Medrad Stellant CT Injector System with XDS Accessory (2007), 6 descendants of its own

## Recalls of this device
- Oct 10, 2005 · Not classified · Z-0154-06: the heat maintainer, an accessory, may overheat and deform the disposable syringe

## 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 ISI module option is intended for the specific purpose of allowing an injector to interface with a CT scanner.

Source page: https://510kreport.com/device/K033881
Methodology: https://510kreport.com/methodology