FDA Grants 510(k) Clearance to Royal Philips for its Spectral Diagnostic Suite

The FDA has granted 510(k) clearance to Netherlands-based Royal Philips to market its Spectral Diagnostic Suite, a set of advanced visualization and analysis tools designed to deliver enhanced spectral viewing and advanced clinical applications capabilities.

The tools allow clinicians to utilize the spectral information on-demand to achieve better clinical decision support without the complexity of special modes or workstations that disrupt user workflow.

Physicians can analyze incidental findings since patients do not have to come back for additional imaging.

SpDS features enhanced comprehensive cardiac analysis, vessel analysis and tumor tracking. — Michael Cipriano