RW-1

RW-1 is medical imaging software that receives, stores, processes, and displays sequential DICOM images from chest fluoroscopy (RF and AX modalities). It visualizes intensity modulation using FFT filtering to generate differential projection images (RDP and BDP) and time-compressed summary images. The software is not for primary diagnosis and is intended for adult patients only.

Both subject and predicate devices are software-based systems that receive, process, display, and transmit X-ray digital images via DICOM 3.0. The RW-1 has fewer image processing modes (RDP, BDP only) compared to the predicate's nine modes, and fewer display and measurement functions. These differences represent reductions in functionality and architectural simplifications rather than new capabilities.

ISO 13485 clauses 7.3 (Design controls), 8.3 (Nonconforming product), and 8.5 (Corrective and preventative action); FDA guidance on Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions.

The RW-1 is substantially equivalent to the predicate KONICAMINOLTA DI-X1 because both are software-based medical imaging systems with the same core intended use of receiving, processing, and displaying DICOM X-ray images. The observed differences—fewer processing modes, display functions, and measurement tools—represent functional reductions and architectural simplifications that do not raise new safety or effectiveness questions.