Medical Device Manufacturer · US , Knoxville , TN

Cti Pet Systems, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1991
19
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cti Pet Systems, Inc. Radiology
19 devices
1-19 of 19
Cleared Mar 25, 2005
LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I
K050509 · KPS
Radiology · 24d
Cleared Oct 01, 2004
LSO PET/CT HIREZ 64
K042467 · KPS
Radiology · 18d
Cleared Jun 07, 2004
ECAT HRRT
K040933 · KPS
Radiology · 59d
Cleared Nov 20, 2003
LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
K033431 · KPS
Radiology · 23d
Cleared Nov 25, 2002
ECAT PET/CT
K023768 · KPS
Radiology · 13d
Cleared Nov 08, 2002
ECAT LSO PET/CT 16
K023518 · KPS
Radiology · 18d
Cleared Aug 14, 2002
ECAT VISION PET SCANNER, MODELS 3000 & 5000
K021633 · KPS
Radiology · 89d
Cleared Oct 31, 2001
MODIFICATION TO: ECAT LSO PET/CT SCANNER
K013504 · KPS
Radiology · 9d
Cleared Dec 13, 2000
ECAT PET SCANNER
K003241 · KPS
Radiology · 57d
Cleared Nov 16, 2000
ECAT ACCEL PET SCANNER
K002584 · KPS
Radiology · 87d
Cleared Oct 31, 2000
ECAT PET SCANNER
K002715 · KPS
Radiology · 61d
Cleared Sep 27, 2000
ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART
K002039 · LLZ
Radiology · 84d
Cleared Jun 08, 1998
E.CAM LSO 311 PET/SPECT SYSTEM
K981027 · KPS
Radiology · 81d
Cleared Feb 25, 1998
ECAT PET SCANNERS
K974256 · KPS
Radiology · 104d
Cleared Oct 15, 1996
ECAT EXACT & ECAT EXACT HR+
K962797 · KPS
Radiology · 89d
Cleared Mar 22, 1994
ECAT PRT
K940478 · KPS
Radiology · 48d
Cleared Apr 27, 1992
ECAT EXACT HR MODEL 961
K920624 · KPS
Radiology · 76d
Cleared Nov 27, 1991
ECAT SCANNER (MODEL 921)
K913637 · KPS
Radiology · 104d
Cleared May 17, 1991
ECAT SCANNER
K910048 · KPS
Radiology · 130d
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