Devices · Ankon Technologies co., ltd

NaviCam ProScan

Ankon Technologies co., ltd is listed for NaviCam ProScan (DEN230027). The FDA list gives December 12, 2023 as the date of the final decision. The lead panel is Gastroenterology-Urology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QZF as “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. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230027

Official FDA database record

Date of final decision

December 12, 2023

Company on the FDA list

Ankon Technologies co., ltd

Lead panel

Gastroenterology-Urology

Primary product code

QZF

openFDA device name for the code

Gastrointestinal Capsule Endoscopy Analysis Software Device

Device class

2

Regulation number

876.1540

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned