The following data is part of a premarket notification filed by Cti Pet Systems, Inc. with the FDA for Lso Pet/ct Hirez Series, Models 2i, 6i, 16i, 64i.
| Device ID | K050509 |
| 510k Number | K050509 |
| Device Name: | LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I |
| Classification | System, Tomography, Computed, Emission |
| Applicant | CTI PET SYSTEMS, INC. 810 INNOVATION DR. Knoxville, TN 37932 -2571 |
| Contact | Alaine Medio |
| Correspondent | 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-01 |
| Decision Date | 2005-03-25 |
| Summary: | summary |