# K161740: D-SPECT Scanner, D-SPECT L Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Dynamics Medical, Ltd.
- Decided: Nov 4, 2016 after 133 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: 6 generations back to K943574 (1994). 30 ancestors in all.
5 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)
- K110507: Cardiac Scanner and Processing System, Spectrum Dynamics (Israel), Ltd. (2011) Summary page 5.

## Most influential descendants
- K180514: Veriton NM (2018), 4 descendants of its own
- 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
The D-SPECT® Cardiac Scanner is an emission computed tomography system intended for detection of radioisotope tracer uptake in the patient's body and produce cross-sectional images through computer reconstruction of the data. The system uses a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated and Dynamic) and tomographic mode (Static, Multi-gated and Dynamic). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include gating by physiological signals, real-time body movement control, and low count rate (low dose) acquisition without loss of image quality. The D-SPECT® Cardiac Scanner may consist analysis and display equipment contain data and image processing software to produce images in a variety of trans-axial and reformatted planes. To perform analysis and uptake quantitation and to apply the appropriate filters. The system utilizes combined images for attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration and fusion). The D-SPECT® Cardiac Scanner is intended for use by the appropriately trained healthcare professionals to aid in detecting, localizing and diagnosing of (but not limited) cardiac or individual organs diseases. The system output can be used for planning, guiding, and monitoring therapy.

Source page: https://510kreport.com/device/K161740
Methodology: https://510kreport.com/methodology