Gastroenterology-Urology · De Novo · 2023
NaviCam ProScan
Ankon Technologies co., ltd. Granted by FDA on 12 December 2023 under submission DEN230027, product code QZF (gastrointestinal capsule endoscopy analysis software device). What FDA's record says, in FDA's words.
Device record · DEN230027
- Device. NaviCam ProScanDEVICE
- Company. Ankon Technologies co., ltdCOMPANY
- Decision. 12 December 2023, De NovoDECISION
- Panel. Gastroenterology-UrologyPANEL
- Product code. QZF, Gastrointestinal Capsule Endoscopy Analysis Software DeviceCODE
- Regulation. 21 CFR 876.1540, Class IIREG
- Source. FDA database entry · decision document (16 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
The NaviCam ProScan is indicated as follows: NaviCam ProScan is an artificial intelligence (AI) assisted reading tool designed to aid small bowel capsule endoscopy reviewers in decreasing the time to review capsule endoscopy images for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding. The clinician is responsible for conducting their own assessment of the findings of the AI-assisted reading through review of the entire video, as clinically appropriate. ProScan also assists small bowel capsule endoscopy reviewers in identifying the digestive tract location (oral cavity and beyond, De Novo Summary (DEN230027) esophagus, stomach, small bowel) of the image in adults. This tool is not intended to replace clinical decision making.
The product code's definition, from FDA's classification record. 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 the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedendoscopy
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QZF. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QZF, in Gastroenterology-Urology, or granted in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.