Medical Device Manufacturer · US , Knoxville , TN

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

19 submissions · 19 cleared · Since 1991

Recent clearances: LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I, LSO PET/CT HIREZ 64, ECAT HRRT

19

Total

19

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cti Pet Systems, Inc. Radiology ✕

19 devices

1-12 of 19

Cleared Mar 25, 2005

LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I

Radiology · 24d

Cleared Oct 01, 2004

LSO PET/CT HIREZ 64

Radiology · 18d

Cleared Jun 07, 2004

Radiology · 59d

Cleared Nov 20, 2003

LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ

Radiology · 23d

Cleared Nov 25, 2002

Radiology · 13d

Cleared Nov 08, 2002

ECAT LSO PET/CT 16

Radiology · 18d

Cleared Aug 14, 2002

ECAT VISION PET SCANNER, MODELS 3000 & 5000

Radiology · 89d

Cleared Oct 31, 2001

MODIFICATION TO: ECAT LSO PET/CT SCANNER

Radiology · 9d

Cleared Dec 13, 2000

ECAT PET SCANNER

Radiology · 57d

Cleared Nov 16, 2000

ECAT ACCEL PET SCANNER

Radiology · 87d

Cleared Oct 31, 2000

ECAT PET SCANNER

Radiology · 61d

Cleared Sep 27, 2000

ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART

Radiology · 84d