510(k) DEN230027
DEN230027 is an FDA 510(k) premarket notification submitted by Ankon Technologies Co., Ltd. for the device "NaviCam ProScan". The FDA issued a decision of De Novo Granted on December 12, 2023. The device falls under product code QZF (Gastrointestinal Capsule Endoscopy Analysis Software Device), a Class II device regulated under 21 CFR 876.1540. Ankon Technologies Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 12, 2023
- Date Received
- April 14, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointestinal Capsule Endoscopy Analysis Software Device
- Device Class
- Class II
- Regulation Number
- 876.1540
- Review Panel
- GU
- Submission Type
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.