DEN230027 is an FDA 510(k) submission for the NaviCam ProScan. This device is classified as a Gastrointestinal Capsule Endoscopy Analysis Software Device (Class II - Special Controls, product code QZF).
Submitted by Ankon Technologies Co., Ltd. (Wuhan, CN). The FDA issued a Not Cleared (DENG) decision on December 12, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1540. 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) Number | DEN230027 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 14, 2023 |
| Decision Date | December 12, 2023 |
| Days to Decision | 242 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | QZF - Gastrointestinal Capsule Endoscopy Analysis Software Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1540 |
| 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. |