510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN210032Unknown

AccuMeasure System

Rqmis Inc., Amesbury MA / Direct, Unknown
FDA source (opens on fda.gov)

DEN210032 is the FDA 510(k) clearance record for AccuMeasure System, a class II device, cleared for RQMIS, Inc. on under FDA product code QTH (Endoscopic Light-Projecting Measuring Device). FDA's definition for product code QTH reads: "An endoscopic light-projecting measuring device projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest". FDA records list one 510(k) clearance for RQMIS, Inc. As of , FDA records show no recalls naming DEN210032.

Clearance record

Decision date
Received
(351 days to decision)
Product code
QTH Endoscopic Light-Projecting Measuring Device
Regulation
21 CFR 876.1530
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
RQMIS, Inc. 110 Haverhill Rd., Amesbury MA
Third party review
No

Clearances, product code QTH

Trailing 12 months

FDA records hold no clearances under product code QTH in the trailing twelve months.

FDA records show no clearances under product code QTH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QTH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260