NaviCam ProScan is an AI-enabled medical device from Ankon Technologies co., ltd that the U.S. FDA granted through De Novo DEN230027 on December 12, 2023. Its lead review panel is Gastroenterology-Urology and its primary product code is QZF (Gastrointestinal Capsule Endoscopy Analysis Software Device).
See also FDA-cleared AI gastroenterology-urology devices in 2023, all FDA AI clearances in 2023, top gastroenterology-urology AI devices.
Key facts
| Submission number | DEN230027 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Ankon Technologies co., ltd |
| Lead review panel | Gastroenterology-Urology |
| Primary product code | QZF — Gastrointestinal Capsule Endoscopy Analysis Software Device |
| Applicant (openFDA) | Ankon Technologies Co., Ltd. |
| Applicant location | Wuhan, CN |
| Device class | Class 2 |
| Regulation number | 21 CFR 876.1540 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. NaviCam ProScan went through this pathway (DEN230027).
openFDA lists it as a Class 2 device under 21 CFR 876.1540. Class II devices are moderate risk and are subject to general and special controls.
Product code QZF covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. Ankon Technologies co., ltd has 1 AI-enabled device on the list, and the Gastroenterology-Urology panel accounts for 27 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.