The following data is part of a premarket notification filed by Cti Pet Systems, Inc. with the FDA for Ecat Pet/ct; Ecat Lso Pet/ct; Ecat Lso Pet/ct 16.
| Device ID | K023768 |
| 510k Number | K023768 |
| Device Name: | ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | CTI PET SYSTEMS, INC. 810 INNOVATION DR. Knoxville, TN 37932 -2571 |
| Contact | William Skremsky |
| Correspondent | William Skremsky CTI PET SYSTEMS, INC. 810 INNOVATION DR. Knoxville, TN 37932 -2571 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-12 |
| Decision Date | 2002-11-25 |
| Summary: | summary |