QTH
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Endoscopic Light-Projecting Measuring Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1530
- Medical specialty
- Gastroenterology, Urology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| AccuMeasure System (DEN210032) | RQMIS, Inc. | 2022-07-26 |
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