# K983826: 3S Injector-CT Contrast Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Unimachs Corp.
- Decided: Mar 23, 2000 after 511 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 K864227 (1987). 4 ancestors in all.
19 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880493: Medrad Microprocessor CT Injection System, Medrad, Inc. (1988) Summary page 1.
- K924116: Medrad MCT, MCT Plus Injector/Medrad Front Load, Medrad, Inc. (1993) Summary page 1.
- K912944: CT 8000 Digital Injection System, Mallinckrodt Group, Inc. (1992) Summary page 1.
- K864227: Percupump (TM), E-Z-Em, Inc. (1987) Summary page 1.

## Most influential descendants
- 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
- K192657: Sterile High-pressure Angiographic Syringes for Single-use (2020), 4 descendants of its own
- K211564: Sterile High-pressure Angiographic Syringes for Single-use (2021), 2 descendants of its own

## Indications for use
The 3S INJECTOR - CT is intended for the administration of contrast media into patients for diagnostic x-ray studies.

Source page: https://510kreport.com/device/K983826
Methodology: https://510kreport.com/methodology