DeviceClearance

Product code QTH— Gastroenterology, Urology

AccuMeasure System

Classification name
Endoscopic Light-Projecting Measuring Device
Device class
Class 2
Regulation
21 CFR 876.1530
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QTH under 21 CFR 876.1530, via openFDA

Market context for product code QTH

FDA has cleared 1 device under product code QTH, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QTH

Recent clearances under product code QTH

Data sourced from openFDA. This site is unofficial and independent of the FDA.