Hybrid Viewer (00859873006240)

Hybrid Viewer is a software application that processes, displays, and analyzes nuclear medicine and radiology imaging data in 2D and 3D. It provides general tools like scrolling, zooming, filtering, and motion correction, along with dedicated workflows optimized for specific investigations in neurology, cardiology, gastroenterology, hepatology, pneumology, osteology, and nephrology. The results inform clinical management but do not replace visual assessment.

Hybrid Viewer version 7.2 employs the same fundamental technology as its predicate version 7.0. The primary difference is the addition of the Centiloid scale for neurology investigations. Both are software-only devices with identical intended use, indications, primary device function (image analysis), and use environment. Other changes are bug fixes or ease-of-use improvements that do not alter available results or algorithms.

Not stated in this summary.

The subject device maintains the same safety and effectiveness profile as the predicate because the fundamental design and operating principles remain unchanged. Non-clinical performance testing validates that the new Centiloid algorithm performs as expected with correlation coefficients exceeding 0.96 and mean values within ±2% of published reference values. Software verification and validation testing confirms the device operates as intended at the appropriate documentation level for its risk profile.