# K031571: Empowercta Injector System, Models 9930 & 9910 & 9825

- Pathway: 510(k) (Special)
- Applicant: E-Z-Em, Inc.
- Decided: Jun 19, 2003 after 30 days
- Product code: IZQ (Injector, Contrast Medium, Automatic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011160 (2001). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011160: E-Z EM Percupump 2001 CT Injector, E-Z-Em, Inc. (2001)

## Most influential descendants
- K063029: Empower CT/Cta Injector System, Model 9800/9900 (2006), 2 descendants of its own
- K071378: Modification to Empower CT/Cta Injector System, Models 9800/9900 Product Series (2007), 1 descendant of its own
- K262115: VueJect® Ultrasound Enhancing Agent Delivery System (2026), 0 descendants of its own

## Recalls of this device
- Dec 3, 2004 · Not classified · Z-0548-05: Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket 
- Dec 3, 2004 · Not classified · Z-0549-05: Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket 
- Dec 3, 2004 · Not classified · Z-0550-05: Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket 

## Indications for use
CT Injector: Administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body. EDA: The Extravasation Detection Accessory is indicated for the detection of extravasations of contrast media during CT using a power injector.

Source page: https://510kreport.com/device/K031571
Methodology: https://510kreport.com/methodology