# K062449: Empowermr Injector System, Model 9730

- Pathway: 510(k) (Abbreviated)
- Applicant: E-Z-Em, Inc.
- Decided: Apr 13, 2007 after 234 days
- Product code: IZQ (Injector, Contrast Medium, Automatic)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Vascular administration of contrast media and flushing media in conjunction with magnetic resonance (MR) imaging.

Source page: https://510kreport.com/device/K062449
Methodology: https://510kreport.com/methodology