FDA 510(k) Applications Submitted by CTI PET SYSTEMS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K050509 |
03/01/2005 |
LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I |
CTI PET SYSTEMS, INC. |
| K040933 |
04/09/2004 |
ECAT HRRT |
CTI PET SYSTEMS, INC. |
| K042467 |
09/13/2004 |
LSO PET/CT HIREZ 64 |
CTI PET SYSTEMS, INC. |
| K981027 |
03/19/1998 |
E.CAM LSO 311 PET/SPECT SYSTEM |
CTI PET SYSTEMS, INC. |
| K021633 |
05/17/2002 |
ECAT VISION PET SCANNER, MODELS 3000 & 5000 |
CTI PET SYSTEMS, INC. |
| K002039 |
07/05/2000 |
ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART |
CTI PET SYSTEMS, INC. |
| K962797 |
07/18/1996 |
ECAT EXACT & ECAT EXACT HR+ |
CTI PET SYSTEMS, INC. |
| K002584 |
08/21/2000 |
ECAT ACCEL PET SCANNER |
CTI PET SYSTEMS, INC. |
| K002715 |
08/31/2000 |
ECAT PET SCANNER |
CTI PET SYSTEMS, INC. |
| K003241 |
10/17/2000 |
ECAT PET SCANNER |
CTI PET SYSTEMS, INC. |
| K023518 |
10/21/2002 |
ECAT LSO PET/CT 16 |
CTI PET SYSTEMS, INC. |
| K013504 |
10/22/2001 |
MODIFICATION TO: ECAT LSO PET/CT SCANNER |
CTI PET SYSTEMS, INC. |
| K033431 |
10/28/2003 |
LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ |
CTI PET SYSTEMS, INC. |
| K023768 |
11/12/2002 |
ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 |
CTI PET SYSTEMS, INC. |
| K974256 |
11/13/1997 |
ECAT PET SCANNERS |
CTI PET SYSTEMS, INC. |
|
|
