RW-1
Mediott, Inc.RW-1 is a medical imaging software designed to visualize intensity modulation in sequential chest fluoroscopy images, enhancing image details such as dynamic changes over time. It aids clinicians by providing processed views of chest X-ray data to support assessment but is not intended for primary diagnosis. The software operates standalone and integrates image processing like FFT filtering to visualize physiological changes in adult patients' chest images.
Intended Use
Visualization of various intensity modulation including FFT filter in sequential DICOM images primarily from low-dose chest fluoroscopy (RF and AX modalities). Not intended for primary diagnosis, reference images such as scintigraphy or CT may be displayed for supplementary purposes. Intended for adult patients only.
Technology
Software receives, stores, processes, and displays sequential DICOM images via DICOM-compliant communication. It includes FFT-based intensity modulation mode processing to extract frequency components in chest dynamics and generates differential projection images (RDP, BDP) and time-compressed summary images (MEDP, MIDP, MBDP). Operates as a standalone application integrating all processing and visualization.
Performance
Non-clinical performance testing was conducted via system-level verification and validation to confirm reliable and consistent software algorithm operation under representative conditions. No standalone bench tests were performed beyond this, consistent with standard medical software practices. Cybersecurity considerations per FDA guidance were addressed. Results showed substantial equivalence to predicate with no new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Ready to Sharpen Your Edge?
Subscribe to join 11k+ peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.