Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright

The Senographe Pristina system is a full-field digital mammography platform for screening and diagnostic breast imaging. It includes SenoBright HD for contrast-enhanced spectral mammography, Pristina Serena for stereotactic biopsy guidance, and Pristina Serena Bright for contrast-enhanced biopsy guidance. All configurations generate digital mammographic images for visualization, archiving, and interventional procedure support.

The subject devices retain identical X-ray generation, acquisition chain, detector technology, and physical structure as the predicate. Key changes include an updated image post-processing algorithm (MV processing replacing eContrast), an optional adjustable-height control station, RFID-based login, updated operating system, additional detector coating and gain module, and expanded biopsy device compatibility (ATEC, Brevera). No changes to X-ray tube, generator, filters, collimation, or automatic exposure control.

Development conducted under ISO 13485 (Quality Management System) and 21 CFR 820 (Quality System Regulations). Testing referenced FDA Class II Special Controls Guidance for Full Field Digital Mammography Systems (November 5, 2013). Testing included standard verification per mammography phantom protocols and ACR Quality Control Manual criteria.

The MV post-processing algorithm maintains the same fundamental workflow and principles as the predicate eContrast algorithm with refinements to improve consistency. Comprehensive testing—including detectability studies, ACR phantom scoring, and clinical image evaluation by MQSA-qualified radiologists—demonstrated equivalent image quality and performance with no degradation in safety or effectiveness. All predefined acceptance criteria were met, and cumulative modifications since the prior clearance do not alter intended use, indications, safety, or essential performance.