21 CFR 876.1530 — Endoscopic Light-Projecting Measuring Device
Gastroenterology, Urology (GU) · Subpart B—Diagnostic Devices · § 876.1530
Identification
An endoscopic light-projecting measuring device is an accessory used in conjunction with an endoscope to project light on a mucosal surface and use software to determine the dimensions of observable anatomy and pathology in the gastrointestinal tract. The device provides no therapeutic or diagnostic function.
Classification Rationale
Class II (special controls). The device is classified as Class II because it is not a device for which general controls alone are sufficient to provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls to provide such assurance.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QTH | Endoscopic Light-Projecting Measuring Device | 2 | 1 | SaMD |
Special Controls
QTH — Endoscopic Light-Projecting Measuring Device
In combination with the general controls of the FD&C Act, the endoscopic light-projecting measuring device is subject to the following special controls:
De Novo Order DEN210032
