RW-1

RW-1 is a software-only medical imaging system that receives, stores, processes, and displays sequential DICOM images primarily from chest fluoroscopy (RF and AX modalities). It runs as a standalone application on commercial personal computers and communicates with hospital PACS systems via DICOM protocols. The device is not intended for primary diagnosis; reference images such as scintigraphy or CT scans may be displayed for supplementary purposes.

Both RW-1 and the predicate device (KONICAMINOLTA DI-X1) are software-based systems that receive, process, display, and transmit X-ray digital images using DICOM 3.0. RW-1 has fewer display functions (lacks annotation and overlay), fewer measurement tools (area only versus distance, angle, area, and CTR), and operates as a standalone client rather than a multi-client server architecture. These differences represent reductions in functionality and architectural simplifications rather than new capabilities.

Not stated in this summary.

Substantial equivalence is claimed because both devices share the same intended use (evaluation of chest fluoroscopy images), the same input/output protocols (DICOM 3.0 storage), and core display and processing functions (density/gradation adjustment, rotation, scaling, panning, cine display, image comparison). The differences are one-directional reductions in scope—RW-1 lacks annotation, overlay, and certain measurement tools present in the predicate—which do not introduce new safety or effectiveness questions. Non-clinical performance testing confirmed that RW-1's algorithms operate reliably under representative conditions. Because the subject device retains all core capabilities necessary for its intended use and only simplifies or removes additional features, it is substantially equivalent to the predicate device.