DEN210032 is an FDA 510(k) submission for the AccuMeasure System. This device is classified as a Endoscopic Light-projecting Measuring Device (Class II - Special Controls, product code QTH).
Submitted by RQMIS, Inc. (Amesbury, US). The FDA issued a Not Cleared (DENG) decision on July 26, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1530. An Endoscopic Light-projecting Measuring Device Projects Light On A Mucosal Surface And Uses Software To Determine The Dimensions Of Observable Features Of Interest..
| 510(k) Number | DEN210032 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 09, 2021 |
| Decision Date | July 26, 2022 |
| Days to Decision | 351 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | QTH - Endoscopic Light-projecting Measuring Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1530 |
| 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. |