# K160120: D-SPECT Processing and Reviewing Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Dynamics, Ltd.
- Decided: Mar 21, 2016 after 62 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.
2 later devices descend from it; 1 cites it directly.
0 of 33 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 7.

## Most influential descendants
- K212230: TruSPECT  Radiological Image Processing Station (2021), 1 descendant of its own
- K253532: TruSPECT Processing Station (2025), 0 descendants of its own

## Indications for use
The D-SPECT® Processing and Reviewing Workstation is intended for Processing, Reporting, Archiving, Display, Communication and Analysis of emission computerized tomography data using tools for imaging and automated review and quantification of Cardiac SPECT data. The D-SPECT® Processing and Reviewing Workstation is intended to work with Spectrum Dynamics’ D-SPECT® Cardiac Scanner System or as a separate standalone post processing workstation. The system is intended for use by the Nuclear Medicine (NM), Radiology or Electro Physiology Cardiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Dynamic, Multi-Gated) and tomographic three-dimensional scans (SPECT, Gated SPECT) acquired by gamma cameras. The system can run on a dedicated workstation or as part of Spectrum Dynamics’ D-SPECT® Cardiac Scanner System. The NM data can be coupled with registered and/or fused X-Ray CT or MR scans, and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. "SUMO" optional application enables visual evaluation and assessment of the sympathetic innervation system of the heart by quantification of uptake ratios between regions of interest, identifying discreet uptake areas of mIBG I-123 (AdreView tm Iobenguane I-123 Injection) or similar agents within the heart.

Source page: https://510kreport.com/device/K160120
Methodology: https://510kreport.com/methodology