Company ยท US
Cti Pet Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2005. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 25, 2005 | K050509 | LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I Cti Pet Systems, Inc. | KPS |
| Oct 1, 2004 | K042467 | LSO PET/CT HIREZ 64 Cti Pet Systems, Inc. | KPS |
| Jun 7, 2004 | K040933 | ECAT HRRT Cti Pet Systems, Inc. | KPS |
| Nov 20, 2003 | K033431 | LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ Cti Pet Systems, Inc. | KPS |
| Nov 25, 2002 | K023768 | ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 Cti Pet Systems, Inc. | KPS |
| Nov 8, 2002 | K023518 | ECAT LSO PET/CT 16 Cti Pet Systems, Inc. | KPS |
| Aug 14, 2002 | K021633 | ECAT VISION PET SCANNER, MODELS 3000 & 5000 Cti Pet Systems, Inc. | KPS |
| Oct 31, 2001 | K013504 | MODIFICATION TO: ECAT LSO PET/CT SCANNER Cti Pet Systems, Inc. | KPS |
| Dec 13, 2000 | K003241 | ECAT PET SCANNER Cti Pet Systems, Inc. | KPS |
| Nov 16, 2000 | K002584 | ECAT ACCEL PET SCANNER Cti Pet Systems, Inc. | KPS |
| Oct 31, 2000 | K002715 | ECAT PET SCANNER Cti Pet Systems, Inc. | KPS |
| Sep 27, 2000 | K002039 | ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART Cti Pet Systems, Inc. | LLZ |
| Jun 8, 1998 | K981027 | E.CAM LSO 311 PET/SPECT SYSTEM Cti Pet Systems, Inc. | KPS |
| Feb 25, 1998 | K974256 | ECAT PET SCANNERS Cti Pet Systems, Inc. | KPS |
| Oct 15, 1996 | K962797 | ECAT EXACT & ECAT EXACT HR+ Cti Pet Systems, Inc. | KPS |
| Mar 22, 1994 | K940478 | ECAT PRT Cti Pet Systems, Inc. | KPS |
| Apr 27, 1992 | K920624 | ECAT EXACT HR MODEL 961 Cti Pet Systems, Inc. | KPS |
| Nov 27, 1991 | K913637 | ECAT SCANNER (MODEL 921) Cti Pet Systems, Inc. | KPS |
| May 17, 1991 | K910048 | ECAT SCANNER Cti Pet Systems, Inc. | KPS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2005 | CTI PET Systems Inc ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions
ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc.
Sceptre an Terminated |
KPS | K002584 K003241 +1 |
| Feb 16, 2005 | CTI PET Systems Inc PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems:
Siemens Models: Biograph PET/CT
CTI Models: Reveal Terminated |
KPS | K002715 K013504 +3 |
| Nov 13, 2003 | Cti Pet Systems Inc Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT Terminated |
KPS | K002715 K013504 |
| Mar 21, 2003 | Cti Pet Systems Inc ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems:
Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECA Terminated |
KPS | K002584 K913637 +3 |