Tag: 510k clearance

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Philips AI-powered, software-defined magnetic resonance software receives 510(k) clearance

Philips has announced that its SmartSpeed artificial intelligence (AI)-powered magnetic resonance (MR) acceleration software has received US Food and Drug Administration (FDA) 510(k) clearance....
Surmodics

Surmodics receives FDA 510(k) clearance for Sublime radial access 0.014 RX...

Surmodics recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its Sublime radial access 0.014 rapid exchange (RX) percutaneous...