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Ecat Exact & Ecat Exact Hr+

by Cti Pet Systems, Inc. 510(k)

Active United States

510(k) K962797

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK962797 Date15 Oct 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

14 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0248-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007
    • Terminated Z-0249-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007
    • Terminated Z-0250-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007
    • Terminated Z-0247-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007
    • Terminated Z-0246-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007
    • Terminated Z-0251-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007
    • Terminated Z-0252-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007

    Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols)

  • 4 recalls, same reason

    • Terminated Z-0269-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007
    • Terminated Z-0270-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007
    • Terminated Z-0272-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007
    • Terminated Z-0271-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007

    Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.

    • Terminated Z-0273-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007

    Incorrect Data Results - ECAT System's software versions 7.2.2 and 7.4 may calculate the decay correction for emission data incorrectly while performing whole-body studies with all transmissions followed by all emissions.

    • 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.

    • Terminated Z-0674-03 FDA Unclassified (pre-2012) initiated 4 Mar 2003

    Incorrect patient information is displayed in the reconstructed images of a whole body patient scan.

Specification

510(k)

510(k) Number
FDA Product Code
KPS
Device Class
Class II
Regulation
21 CFR Part 892.1200
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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