WASHINGTON, June 4 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final amendment and final order classifying the radiological acquisition or optimization guidance system. This rule places the device into Class II, subject to special controls, aiming to ensure its safety and effectiveness while enhancing patient access to beneficial innovative devices and reducing regulatory burdens.

This classification was achieved via the De N . . .

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