Aeka Imaging

Aeka Imaging is a web-based dental imaging software application that acquires, displays, processes, edits, annotates, reviews, stores, prints, and distributes patient dental images. It receives images from various dental acquisition devices including digital X-ray sensors, intraoral cameras, panoramic devices, and generic devices such as scanners, and operates on standard PC hardware under Windows 11 or macOS.

Aeka Imaging is Class II, DICOM-compliant software supporting intraoral radiographic devices, intraoral cameras, and panoramic X-ray devices. Key differences from predicate include hosting on AWS EKS (vs. Microsoft Azure), frontend programming in Angular/TypeScript/JavaScript with C# backend and MySQL database (vs. C# with Azure SQL). Both support similar image editing functions (rotate, flip, resize, brightness/contrast adjustment), file formats (DICOM, JPEG, PNG, TIFF, PDF export), and web-based deployment.

IEC 62304 (medical device software lifecycle), ANSI AAMI ISO 14971 (risk management), IEC 62366-1 (usability engineering), NEMA PS 3.1–3.20 (DICOM), ISO/IEC 27001 (information security), and IEEE 11073-40101/40102 (cybersecurity). Software Unit Test, Integration Test, System Test, User Acceptance Testing, Usability Testing, and cybersecurity vulnerability/penetration testing were performed.

Aeka Imaging and predicate SOTA Cloud Imaging (K210682) share the same Class II classification, product code (LLZ), regulatory number (21 CFR 892.2050), and intended use as dental imaging management systems. Both support identical modalities and core image processing functions; bench performance testing confirmed equivalent performance in image quality, acquisition speed, calibration precision, and system stability, raising no new safety or effectiveness concerns.