The following data is part of a premarket notification filed by Cti Pet Systems, Inc. with the FDA for Ecat Hrrt.
| Device ID | K040933 |
| 510k Number | K040933 |
| Device Name: | ECAT HRRT |
| Classification | System, Tomography, Computed, Emission |
| Applicant | CTI PET SYSTEMS, INC. 810 INNOVATION DR. Knoxville, TN 37932 -2571 |
| Contact | M. Alaine Medio |
| Correspondent | M. Alaine Medio CTI PET SYSTEMS, INC. 810 INNOVATION DR. Knoxville, TN 37932 -2571 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-09 |
| Decision Date | 2004-06-07 |
| Summary: | summary |