Ecat Pet Scanner

• • Terminated Z-0712-06 FDA Unclassified (pre-2012) ·initiated 28 Mar 2006

  There is a potential for inaccurate, elevated SUVs (standardized uptake values). On follow-up scans, the elevated SUV could be misinterpreted, and inappropriately impact a patient's treatment plan.

• • Terminated Z-0819-05 FDA Unclassified (pre-2012) ·initiated 5 Apr 2005

  Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit.

510(k) Number

K003241 ↗

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. →