QCR

Wound Autofluorescence Imaging Device

Product code: QCR
Device name: Wound Autofluorescence Imaging Device
Device class: Class 1
21 CFR: 21 CFR 878.4165
Medical specialty: General, Plastic Surgery
Marketing pathway: 510(K) Exempt
510(k) clearances (last 3 years): 1

FDA classification definition

A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.

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

Official FDA classification page: QCR

Classification and pathway per current FDA publications. Data from openFDA (CC0).