# K190457: VERITON CT whole body SPECT/CT system

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Dynamics Medical, Ltd.
- Decided: Jul 12, 2019 after 137 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: 10 generations back to K952674 (1995). 61 ancestors in all.
2 later devices descend from it; 1 cites it directly.
6 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182484: VERITON CT whole body SPECT/CT system, Spectrum Dynamics Medical, Ltd. (2018) Summary page 4.

## Most influential descendants
- K230600: VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (2023), 1 descendant of its own
- K254001: VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (2026), 0 descendants of its own

## Indications for use
The Spectrum Dynamics Medical’s VERITON™ CT is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and trauma. The system output can be used for planning, guiding, and monitoring therapy. SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques; whole body and tomographic imaging. CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles. The CT part is indicated for pediatric and adult patients. SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.

Source page: https://510kreport.com/device/K190457
Methodology: https://510kreport.com/methodology