# K993728: Medrad Envision CT Injector System

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Nov 26, 1999 after 22 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: 1 generation back to K934086 (1995). 1 ancestor in all.
39 later devices descend from it; 3 cite it directly.
0 of 41 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.

## Most influential descendants
- K023183: Medrad Stellant CT Injector System (2003), 36 descendants of its own
- 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

## Indications for use
The EnVision CT Injection System s a syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography applications. It is intended to be used for the specific purpose of injecting intravenous contrast medium into the human vascular system for diagnostic studies in computed tomography.

Source page: https://510kreport.com/device/K993728
Methodology: https://510kreport.com/methodology