# K962797: Ecat Exact & Ecat Exact HR+

- Pathway: 510(k) (Traditional)
- Applicant: Cti Pet Systems, Inc.
- Decided: Oct 15, 1996 after 89 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 5 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K981027: E.Cam Lso 311 Pet/Spect System (1998), 2 descendants of its own
- K130269: Ecat Scintron Pet (2013), 1 descendant of its own
- K201807: Ancoris (2020), 0 descendants of its own
- K040933: Ecat HRRT (2004), 0 descendants of its own
- K021633: Ecat Vision Pet Scanner, Models 3000 & 5000 (2002), 0 descendants of its own

## Recalls of this device
- Jul 23, 2007 · Not classified · Z-0271-2008: 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 transmissi
- Jul 23, 2007 · Not classified · Z-0273-2008: 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 follo
- Jul 23, 2007 · Not classified · Z-0251-2008: 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 reconstr
- Jul 23, 2007 · Not classified · Z-0252-2008: 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 reconstr
- Jul 23, 2007 · Not classified · Z-0270-2008: 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 transmissi
- Jul 23, 2007 · Not classified · Z-0246-2008: 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 reconstr
- Jul 23, 2007 · Not classified · Z-0247-2008: 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 reconstr
- Jul 23, 2007 · Not classified · Z-0249-2008: 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 reconstr
- Jul 23, 2007 · Not classified · Z-0248-2008: 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 reconstr
- Jul 23, 2007 · Not classified · Z-0250-2008: 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 reconstr
- Jul 23, 2007 · Not classified · Z-0269-2008: 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 transmissi
- Jul 23, 2007 · Not classified · Z-0272-2008: 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 transmissi
- Apr 5, 2005 · Not classified · Z-0819-05: 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 tra
- Mar 4, 2003 · Not classified · Z-0674-03: Incorrect patient information is displayed in the reconstructed images of a whole body patient scan.

Source page: https://510kreport.com/device/K962797
Methodology: https://510kreport.com/methodology