QTH

Endoscopic Light-Projecting Measuring Device

Product code: QTH
Device name: Endoscopic Light-Projecting Measuring Device
Device class: Class 2
21 CFR: 21 CFR 876.1530
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification definition

An endoscopic light-projecting measuring device projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest.

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

Official FDA classification page: QTH

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