AS Software Version Asera

AS Software Version Asera is a web-based medical image management and processing system designed to automate patient information management. It enables ultrasound image acquisition, review, documentation, storage, archiving, and reporting for use by healthcare professionals including sonographers, obstetricians, gynecologists, radiologists, and cardiologists in hospitals and medical offices.

The device is a software-only system using commercial off-the-shelf hardware without dedicated energy requirements. It interfaces with DICOM and HL7 standards, supports ultrasound modalities, and employs serverless cloud hosting on AWS with a modern frontend framework enabling multitenancy. Data security falls under the manufacturer's SOC 2 and HIPAA compliance.

Cybersecurity testing was conducted according to the FDA Guidance Document 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions' from June 2025. The device is subject to Quality Management System Regulation (QMSR) including ISO 13485 clauses 7.3, 8.3, and 8.5.

AS Software Version Asera is substantially equivalent to the predicate AS-OBGYN Information System because both devices have identical intended uses, the same Class II classification, same regulatory number (21 CFR 892.2050), and support the same DICOM and HL7 interfaces for ultrasound imaging. The proposed changes are functionally identical to the predicate, no new safety or effectiveness concerns were raised during testing, and all major features remain the same.