FDA Cautions Consumers Against Use of RoyalVibe Ultrasound Devices
Vesta Teleradiology
JULY 31, 2023
Food and Drug Administration issued a warning to consumers on July 17 about avoiding the use of ultrasound devices from a Texas-based manufacturer and distributor called RoyalVibe Health. However, the FDA has not reviewed these devices, and they lack the necessary 510(k) clearance or premarket approval. What is 510(k) Clearance?
52 
Let's personalize your content