Gastrointestinal Capsule Endoscopy Analysis Software Device
The gastrointestinal capsule endoscopy analysis software device (product code QZF) is a Class 2 Gastroenterology/Urology device (regulation 876.1540) used to analyze pre-recorded capsule endoscopy videos of the gastrointestinal tract suspected of containing lesions, employing software algorithms to identify images and areas of interest to aid clinicians in analyzing suspected lesions. Requiring 510(k) clearance, the device may contain hardware to support interfacing with a capsule imaging system. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QZF
- Device Class
- FDA class 2
- Regulation Number
- 876.1540
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.