Not Cleared Direct

DEN230027 - NaviCam ProScan (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230027 · Ankon Technologies Co., Ltd. · Gastroenterology & Urology device
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Dec 2023
Decision
242d
Days
Class 2
Risk

DEN230027 is an FDA 510(k) submission (not cleared) for the NaviCam ProScan. Classified as Gastrointestinal Capsule Endoscopy Analysis Software Device (product code QZF), Class II - Special Controls.

Submitted by Ankon Technologies Co., Ltd. (Wuhan, CN). The FDA issued a Not Cleared (DENG) decision on December 12, 2023 after a review of 242 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1540 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Gastroenterology & Urology review framework.

View all Ankon Technologies Co., Ltd. devices

Submission Details

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 130d · This submission: 242d
Pathway characteristics

Device Classification

Product Code QZF Gastrointestinal Capsule Endoscopy Analysis Software Device
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.