Digital Image, Storage and Communications, Non-Diagnostic, Laboratory Information System

What Is This Device?

Intended for clinical laboratory image storage and communications. A clinical laboratory image storage and communications device is a device that provides electronic storage and retrieval functions, and provides electronic transfer for non-diagnostic clinical laboratory images. Images are not intended for diagnostic purposes and not intended for radiological images.

What Is FDA Product Code NVV?

Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System is FDA product code NVV, Class 1, 21 CFR 862.2100.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.