Ecat Pet Scanner

• • Terminated Z-0547-05 FDA Unclassified (pre-2012) ·initiated 27 May 2004

  Misalignment of CT and PET scans from performing additional CT scans may produce an incorrect fused data set. In performing additional CT scans, the original PET and CT scans may become misaligned and produce an incorrect fused data set.

• • Terminated Z-0106-04 FDA Unclassified (pre-2012) ·initiated 2 Oct 2003

  CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion.

510(k) Number

K002715 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Ecat Hrrt

  Class II

  FDA 510(k) K040933 Active Cleared 7 Jun 2004

• Ecat Accel Pet Scanner

  Class II

  FDA 510(k) K002584 Active Cleared 16 Nov 2000

• Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez

  Class II

  FDA 510(k) K033431 Active Cleared 20 Nov 2003

• Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I

  Class II

  FDA 510(k) K050509 Active Cleared 25 Mar 2005

• Ecat Pet/CT; Ecat Lso Pet/CT; Ecat Lso Pet/CT 16

  Class II

  FDA 510(k) K023768 Active Cleared 25 Nov 2002

• E.cam Lso 311 Pet/Spect System

  Class II

  FDA 510(k) K981027 Active Cleared 8 Jun 1998

See all devices from Cti Pet Systems, Inc. →