TruSPECT

Primary DI

07649991184103

Basic UDI-DI Code

7649991184TruSPECT6J

Reference

8010290-01

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

Not Intended For Eu Market

Manufacturer

Spectrum Dynamics Medical SA

The TruSPECT is a software-only medical device that will be delivered as pre-installed software on the off-the-shelf PC. TruSPECT includes medical diagnostic applications for visualization, handling, quantitation, analysis, and comparison of medical images from single or multiple imaging modalities at one or more time points. These workflows support functional data, such as single photon emission computed tomography (SPECT) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR). TruSPECT enable visualization of information that would otherwise have to be visually compared disjointedly. TruSPECT is intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with cardiology, electrophysiology, and organ function.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDR).