# K082905: Medrad Stellant CT Injector System with P3T Cardiac

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Jan 12, 2009 after 104 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K934086 (1995). 8 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072886: Medrad Stellant CT Injector System with P3T, Medrad, Inc. (2007) 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

## Recalls of this device
- Aug 2, 2016 · Class II · Z-2768-2016: CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.
- Sep 20, 2013 · Class II · Z-1686-2015: The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not be

## Indications for use
INTENDED USE: P3T Cardiac is intended for use with CT Angiography. P3T Cardiac 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. INDICATIONS FOR USE: P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, and thoracic and abdominal aorta.

Source page: https://510kreport.com/device/K082905
Methodology: https://510kreport.com/methodology