The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Empowercta Injector System, Models 9930 & 9910 & 9825.
| Device ID | K031571 |
| 510k Number | K031571 |
| Device Name: | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 |
| Classification | Injector, Contrast Medium, Automatic |
| Applicant | E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Contact | Steven Hartman |
| Correspondent | Steven Hartman E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Product Code | IZQ |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-20 |
| Decision Date | 2003-06-19 |
| Summary: | summary |