The following data is part of a premarket notification filed by Cti Pet Systems, Inc. with the FDA for Ecat Exact & Ecat Exact Hr+.
| Device ID | K962797 |
| 510k Number | K962797 |
| Device Name: | ECAT EXACT & ECAT EXACT HR+ |
| Classification | System, Tomography, Computed, Emission |
| Applicant | CTI PET SYSTEMS, INC. 810 INNOVATION DR. P.O. BOX 22999 Knoxville, TN 37932 -2562 |
| Contact | William Skremsky |
| Correspondent | William Skremsky CTI PET SYSTEMS, INC. 810 INNOVATION DR. P.O. BOX 22999 Knoxville, TN 37932 -2562 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-18 |
| Decision Date | 1996-10-15 |