# K253532: TruSPECT Processing Station

- Pathway: 510(k) (Special)
- Applicant: Spectrum Dynamics Medical, Ltd.
- Decided: Dec 30, 2025 after 47 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K943574 (1994). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212230: TruSPECT  Radiological Image Processing Station, Spectrum Dynamics Medical, Ltd. (2021) Summary page 5.

## Indications for use
TruSPECT is intended for acceptance, transfer, display, storage, and processing of images for detection of radioisotope tracer uptakes in the patient's body. The device using various processing modes supported by the various clinical applications and various features designed to enhance image quality. The emission computerized tomography data can be coupled with registered and/or fused CT/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. The acquired tomographic image may undergo emission-based attenuation correction. Visualization tools include segmentation, colour coding, and polar maps. Analysis tools include Quantitative Perfusion SPECT (QPS), Quantitative Gated SPECT (QGS) and Quantitative Blood Pool Gated SPECT (QBS) measurements, Multi Gated Acquisition (MUGA) and Heart-to-Mediastinum activity ratio (H/M). The system also includes reporting tools for formatting findings and user selected areas of interest. It is capable of processing and displaying the acquired information in traditional formats, as well as in three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs. TruSPECT is based on Windows operating system. Due to special customer requirements and the clinical focus the TruSPECT can be configured with different combinations of Windows OS based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. TruSPECT is a processing workstation primarily intended for, but not limited to cardiac applications. The workstation can be integrated with the D-SPECT cardiac scanner system or used as a standalone post-processing station.

Source page: https://510kreport.com/device/K253532
Methodology: https://510kreport.com/methodology