# K023768: Ecat Pet/CT; Ecat Lso Pet/CT; Ecat Lso Pet/CT 16

- Pathway: 510(k) (Special)
- Applicant: Cti Pet Systems, Inc.
- Decided: Nov 25, 2002 after 13 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002715 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002715: Ecat Pet Scanner, Cti Pet Systems, Inc. (2000)
- K013504: Modification to: Ecat Lso Pet/CT Scanner, Cti Pet Systems, Inc. (2001)
- K023518: Ecat Lso Pet/CT 16, Cti Pet Systems, Inc. (2002)

## Most influential descendants
- K042428: SCEPTREP3 Pet/CT (2004), 0 descendants of its own

## Indications for use
The PETKT Patient Handling System (PHS) is a system component of CPS ECAT PETKT tomographic scanner systems, which are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The PET/CT Patient Handling System is used to support and move a patient through the PETKT scanner while CT and PET diagnostic image data are being acquired from the patient. The ECAT PET/CT scanners are intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes" taken at different angles. The PET and the CT functions of these systems can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image. ('spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)

Source page: https://510kreport.com/device/K023768
Methodology: https://510kreport.com/methodology