# K033431: Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez

- Pathway: 510(k) (Special)
- Applicant: Cti Pet Systems, Inc.
- Decided: Nov 20, 2003 after 23 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 1 (0 Class I)
- 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.
68 later devices descend from it; 2 cite it directly.
1 of 72 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013504: Modification to: Ecat Lso Pet/CT Scanner, Cti Pet Systems, Inc. (2001) Summary page 1.
- K023518: Ecat Lso Pet/CT 16, Cti Pet Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K060631: Biograph 64 and Biograph 40 (2006), 64 descendants of its own
- K081453: Biograph HD Family (2008), 62 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

## Indications for use
The LSO PET/CT Hi Rez and LSO PET/CT 16 HiRez tomographic scanner systems are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The LSO PETKT Hi Rez and LSO PETKT 16 HiRez 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 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/K033431
Methodology: https://510kreport.com/methodology