# K912944: CT 8000 Digital Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Group, Inc.
- Decided: Feb 4, 1992 after 214 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
No predicates in its family tree.
39 later devices descend from it; 6 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K983826: 3S Injector-CT Contrast Delivery System (2000), 19 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
- K031339: Optibolus (2003), 12 descendants of its own
- K042744: Optiv Antage DH Power Injection System (2004), 11 descendants of its own

## Recalls of this device
- Apr 14, 2008 · Not classified · Z-1828-2008: The tubing metal begins to crack and thin. When this occurs it causes the tubing material to crack around the screws. This can cause the tubing to fall from the mounting plug.

Source page: https://510kreport.com/device/K912944
Methodology: https://510kreport.com/methodology