Rapid DeltaFuse

Rapid DeltaFuse is a medical imaging software that processes Non-Contrast CT (NCCT) images to visualize areas of hypodense and hyperdense tissue in the brain. Trained professionals including physicians and medical technicians use it on standard computers or virtual platforms to view and analyze CT datasets, with the ability to overlay time-differentiated scans of the same patient for comparison.

Rapid DeltaFuse uses traditional coding (rather than AI/ML like its predicate) and accepts only NCCT imaging input, whereas the predicate Rapid accepts CT, CTP, MR, and NCCT. The subject device provides NCCT hyperdensity and hypodensity mapping with time-differentiated overlays, whereas the predicate offers broader functionality including CT/MRI perfusion analysis and MR diffusion modules. Both run on standard off-the-shelf computers or virtual platforms and output processed images to PACS or email.

ISO 14971:2019 (risk management), IEC 62304:2015 (software lifecycle processes), IEC 62366-1:2015 (usability engineering), and NEMA PS 3.1–3.20 (DICOM standard). The device was also tested for cybersecurity using vulnerability assessments, software bill of materials, and penetration testing.

Rapid DeltaFuse is substantially equivalent because it shares the same intended use as the predicate—mapping hyperdense and hypodense tissue regions from NCCT images for neurological analysis. Although the predicate offers additional modules (perfusion, diffusion, dynamic analysis) not present in the subject device, the subject device's core NCCT mapping functionality is identical to the predicate's hyperdensity/hypodensity features. The primary difference—time-differentiated overlays—represents a logical enhancement to the same analytical method rather than a new principle of operation. Validation testing (DICE coefficient 0.94–0.95) confirms equivalent performance, and the device raises no new safety or effectiveness issues.