# K180514: Veriton NM

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Dynamics Medical, Ltd.
- Decided: Apr 25, 2018 after 57 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: 7 generations back to K943574 (1994). 31 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161740: D-SPECT Scanner, D-SPECT L Scanner, Spectrum Dynamics Medical, Ltd. (2016) Summary page 6.

## Most influential descendants
- K182484: VERITON CT whole body SPECT/CT system (2018), 3 descendants of its own
- K190457: VERITON CT whole body SPECT/CT system (2019), 2 descendants of its own
- 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
VERITON™ NM is a Nuclear Medicine (NM) imaging system, intended to perform general nuclear medicine imaging procedures for the detection of radioisotope tracer uptake in a patient’s body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. Scanning modes include whole body and tomographic (static, dynamic and multi-gated) mode, while acquisition types include single and multi-isotope single-photon imaging. Imaging-enhancement features include gating by way of physiological signals and real-time automatic body contouring. The VERITON™ NM system is a medical device intended for use by appropriately-trained healthcare professionals to aid in the detection, localization and diagnosis of diseases and organ function, for the evaluation of diseases, trauma, abnormalities and disorders. System output can be used by a physician for planning, guiding, and monitoring therapy. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: whole body imaging and tomographic imaging. Software: System application software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, CT and other imaging modalities.

Source page: https://510kreport.com/device/K180514
Methodology: https://510kreport.com/methodology