SERV MEDICAL CDSS

SERV MEDICAL CDSS is image processing software for viewing, analyzing, and post-processing Digital Subtraction Angiography (DSA) images acquired through DICOM-compliant imaging devices. It runs on standard off-the-shelf servers and is intended for use by trained healthcare professionals in clinical/hospital settings to support clinical decision-making. The software is not intended for mobile diagnostic use.

Both the subject device and predicate (Brainomix 360° e-CTA) are DICOM-compliant software-only applications running on standard off-the-shelf servers or virtual servers. Both perform standard PACS functions (querying and listing), image viewing, processing, and analysis. The primary difference is supported modality: subject device processes DSA (Digital Subtraction Angiography) while the predicate processes CTA (CT Angiography), though both are DICOM-compliant CT imaging modalities.

Not stated in this summary.

The devices share identical intended use (image visualization and analysis for clinical decision support by trained professionals), identical regulatory classification (Class II, product code LLZ, 21 CFR 892.2050), and identical operational characteristics (DICOM compliance, PACS functionality, software-only deployment). The modality difference (DSA vs. CTA) does not raise new safety or effectiveness concerns because both are DICOM-compliant CT imaging modalities, and software testing demonstrated the subject device met clinical requirements for DSA processing. All safety-relevant factors (materials, biocompatibility, sterility, electrical/mechanical/chemical/thermal/radiation safety) are equivalent as N/A for software-only devices.