NVV

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

Product code
NVV
Device name
Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
Device class
Class 1
21 CFR
21 CFR 862.2100
Medical specialty
Clinical Chemistry
Marketing pathway
510(K) Exempt

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: NVV
Classification and pathway per current FDA publications. Data from openFDA (CC0).