The following data is part of a premarket notification filed by Cti Pet Systems, Inc. with the FDA for Ecat Pet Scanner, Models Ecat Exact And Ecat Exact Hr+ And Ecat Art.
| Device ID | K002039 |
| 510k Number | K002039 |
| Device Name: | ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-05 |
| Decision Date | 2000-09-27 |