# K963071: Angiomat Illumena

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
- Decided: Sep 23, 1997 after 412 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: 1 generation back to K860204 (1986). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860204: Angiomat 6000, Mallinckrodt Group, Inc. (1986) Summary page 1.
- K912944: CT 8000 Digital Injection System, Mallinckrodt Group, Inc. (1992) Summary page 1.

## Most influential descendants
- K092896: Rempress and Angiography Contrast Delivery System Rempress (2010), 1 descendant of its own
- K173450: PRESS DUO elite, PRESS DUO elite AG (2018), 0 descendants of its own
- K082212: Syringe with Handi-Fil (2009), 0 descendants of its own

## Recalls of this device
- May 20, 2011 · Not classified · Z-2859-2011: Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena150mL Syringe with Handi-Fil Straw, product 900101.
- Aug 24, 2007 · Not classified · Z-0056-2008: Synchronization problems: units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit's main console 

## Indications for use
The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals.

Source page: https://510kreport.com/device/K963071
Methodology: https://510kreport.com/methodology