QZF — Gastrointestinal Capsule Endoscopy Analysis Software Device Class II
FDA product code QZF covers "Gastrointestinal Capsule Endoscopy Analysis Software Device", a Class II medical device regulated under 21 CFR 876.1540. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QZF
- Device Class
- Class II
- Regulation Number
- 876.1540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
A gastrointestinal capsule endoscopy analysis software device is used to analyze pre-recorded capsule endoscopy videos of the gastrointestinal tract that are suspected of containing lesions. This device uses software algorithms to identify images and areas of interest as outputs to aid the clinician in analyzing suspected lesions, for clinician review of device outputs. The device may contain hardware to support interfacing with a capsule imaging system.