# K013504: Modification to: Ecat Lso Pet/CT Scanner

- Pathway: 510(k) (Special)
- Applicant: Cti Pet Systems, Inc.
- Decided: Oct 31, 2001 after 9 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002715 (2000). 1 ancestor in all.
73 later devices descend from it; 4 cite it directly.
1 of 75 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002715: Ecat Pet Scanner, Cti Pet Systems, Inc. (2000) Summary page 1.

## Most influential descendants
- K023518: Ecat Lso Pet/CT 16 (2002), 71 descendants of its own
- K033431: Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez (2003), 68 descendants of its own
- K042467: Lso Pet/CT Hirez 64 (2004), 67 descendants of its own
- K050509: Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I (2005), 66 descendants of its own
- K060060: Biograph 6 (2006), 65 descendants of its own

## Recalls of this device
- May 27, 2004 · Not classified · Z-0547-05: 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
- Oct 2, 2003 · Not classified · Z-0106-04: 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.

## Indications for use
The CPS/Siemens ECAT LSO PET/CT system is a combined positron emission tomography (PET) and X-ray computed tomography (CT) scanner. The ECAT LSO PET/CT scanner is 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 this system 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/K013504
Methodology: https://510kreport.com/methodology