The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Empower Ct/cta Injector System, Model 9800/9900.
| Device ID | K063029 |
| 510k Number | K063029 |
| Device Name: | EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | E-Z-EM, INC. 750 SUMMA AVE. Westbury, NY 11590 |
| Contact | Tracey Campbell |
| Correspondent | Tracey Campbell E-Z-EM, INC. 750 SUMMA AVE. Westbury, NY 11590 |
| Product Code | JAK |
| Subsequent Product Code | DSB |
| Subsequent Product Code | IZQ |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-02 |
| Decision Date | 2006-11-02 |
| Summary: | summary |