FDA Product Code QZF: Gastrointestinal Capsule Endoscopy Analysis Software Device
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.
Leading manufacturers include Ankon Technologies Co., Ltd. and Digestaid - Artificial Intelligence Development SA.
FDA 510(k) Cleared Gastrointestinal Capsule Endoscopy Analysis Software Device Devices (Product Code QZF)
About Product Code QZF - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QZF since 2023, with 1 receiving FDA clearance (average review time: 307 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QZF have taken an average of 372 days to reach a decision - up from 242 days historically. Manufacturers should account for longer review timelines in current project planning.
QZF devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →