# K023183: Medrad Stellant CT Injector System

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Jan 10, 2003 after 108 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934086 (1995). 2 ancestors in all.
36 later devices descend from it; 3 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934086: Medrad Envision CT Injector and Qwik Fit Syringe, Medrad, Inc. (1995) Summary page 1.
- K993728: Medrad Envision CT Injector System, Medrad, Inc. (1999) Summary page 1.

## Most influential descendants
- K033881: Medrad Stellant CT Injector System with Imaging System Interface Module (2004), 34 descendants of its own
- 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

## Recalls of this device
- Dec 14, 2018 · Class II · Z-0745-2019: If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.
- Oct 24, 2011 · Not classified · Z-0147-2012: Packaging may exhibit open seals - sterility compromised
- May 24, 2010 · Not classified · Z-1954-2010: Kits contain a T connector that may be susceptible to cracking or breaking or leaking. This could cause product leakage or, less likely, patient injury.
- Oct 10, 2005 · Not classified · Z-0154-06: the heat maintainer, an accessory, may overheat and deform the disposable syringe
- Nov 3, 2004 · Not classified · Z-0257-05: Sterility can be compromised by a tear in the outer packaging.
- Oct 8, 2004 · Not classified · Z-0039-05: Sterility can be compromised by a component tearing the outer packaging

## 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.

Source page: https://510kreport.com/device/K023183
Methodology: https://510kreport.com/methodology