510(k) K031571 ยท IZQ Injector, Contrast Medium, Automatic
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
| Applicant | E-Z-Em, Inc., Westbury NY, US |
| Decision | Substantially Equivalent, Jun 19, 2003 |
| Received | May 20, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031571
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2005 | E-Z-EM, Inc Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886S. Ceiling Column Accessory: The CT and Terminated |
JAK | None listed |
| Feb 16, 2005 | E-Z-EM, Inc Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886M. Ceiling Column Accessory: The CT and Terminated |
JAK | None listed |
| Feb 16, 2005 | E-Z-EM, Inc Brand Name of Device: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886L. Ceiling Column Accessory: T Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.