# K072886: Medrad Stellant CT Injector System with P3T

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Dec 21, 2007 after 73 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). 7 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 15 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.
- K042744: Optiv Antage DH Power Injection System, Mallinckrodt Inc., Liebel-Flarsheim Business (2004) Summary page 1.

## Most influential descendants
- K082905: Medrad Stellant CT Injector System with P3T Cardiac (2009), 5 descendants of its own
- 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

## 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 Stellant P3T software accessory is intended for use in CT angiography of cardiac structures, including coronary arteries, chambers of the heart, and thoracic and abdominal aorta during gated ECG acquisition. The Stellant P3T software accessory computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration. The user will be required to confirm/change the suggested protocol before beginning an injection.

Source page: https://510kreport.com/device/K072886
Methodology: https://510kreport.com/methodology