QTH · Class II · 21 CFR 876.1530

FDA Product Code QTH: Endoscopic Light-projecting Measuring Device

An Endoscopic Light-projecting Measuring Device Projects Light On A Mucosal Surface And Uses Software To Determine The Dimensions Of Observable Features Of Interest.

Leading manufacturers include RQMIS, Inc..

1
Total
0
Cleared
351d
Avg days
2022
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Endoscopic Light-projecting Measuring Device Devices (Product Code QTH)

1 devices
1–1 of 1
Not Cleared Jul 26, 2022
AccuMeasure System
DEN210032
RQMIS, Inc.
Gastroenterology & Urology · 351d

About Product Code QTH - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QTH since 2022, with 0 receiving FDA clearance (average review time: 351 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QTH devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →