# 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

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Medical Care, Inc.
- Decided: Aug 17, 2018 after 248 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: 6 generations back to K934086 (1995). 10 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K082905: Medrad Stellant CT Injector System with P3T Cardiac, Medrad, Inc. (2009) Summary page 5.
- K063090: Medrad Stellant CT Injector System with XDS Accessory, Medrad, Inc. (2007) Summary page 6.

## Most influential descendants
- 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
- 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.

## Indications for use
MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications. MEDRAD® Stellant FLEX Syringe Kits The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications. MEDRAD® Stellant CT Injection System with Certegra Workstation The MEDRAD® Stellant CT Injection System with Certegra Workstation is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications. MEDRAD® Stellant Syringe Kits The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors. MEDRAD® Stellant Connector Tubing The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors. P3T Cardiac P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta. P3T PA P3T PA is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta. P3T Abdomen P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys). ISI The ISI module option is indicated for the specific purpose of allowing an injector to interface with a CT scanner. Connect.CT The Connect.CT application is indicated for the specific purpose of allowing the injector to interface with a CT scanner.

Source page: https://510kreport.com/device/K173773
Methodology: https://510kreport.com/methodology