# K063029: Empower CT/Cta Injector System, Model 9800/9900

- Pathway: 510(k) (Special)
- Applicant: E-Z-Em, Inc.
- Decided: Nov 2, 2006 after 31 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011160 (2001). 2 ancestors in all.
2 later devices descend from it; 1 cites 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) Summary page 1.
- K031571: Empowercta Injector System, Models 9930 & 9910 & 9825, E-Z-Em, Inc. (2003) Summary page 1.

## Most influential descendants
- 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

## Indications for use
Administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner. 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/K063029
Methodology: https://510kreport.com/methodology