Gastroenterology-Urology · 510(k) · 2023
ME-APDS; MAGENTIQ-COLO
Magentiq Eye LTD. Cleared by FDA on 25 July 2023 under submission K223473, product code QNP (gastrointesinal lesion software detection system). What FDA's record says, in FDA's words.
Device record · K223473
- Device. ME-APDS; MAGENTIQ-COLODEVICE
- Company. Magentiq Eye LTD (IL)COMPANY
- Decision. 25 July 2023, 510(k), substantially equivalent (traditional review); received 17 November 2022DECISION
- Panel. Gastroenterology-UrologyPANEL
- Product code. QNP, Gastrointesinal Lesion Software Detection SystemCODE
- Regulation. 21 CFR 876.1520, Class IIREG
- Source. FDA database entry · decision document (17 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The ME-APDS (Magentiq Eye’s Automatic Polyp Detection System) is intended to be used by endoscopists as an adjunct to the common video colonoscopy procedure (screening and surveillance), aiming to assist the endoscopist in identifying lesions during colonoscopy procedure by highlighting regions with visual characteristics consistent with different types of mucosal abnormalities that appear in the colonoscopy video during the procedure. Highlighted regions can be independently assessed by the endoscopist and appropriate action taken according to standard clinical practice. The ME-APDS is trained to process video images which may contain regions consistent with polyps. The ME-APDS is limited for use with standard white-light endoscopy imaging only. The ME-APDS is intended to be used as an adjunct to endoscopy procedures and is not intended to replace histopathological sampling as means of diagnosis.
The product code's definition, from FDA's classification record. A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.
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 namedpathology slides, endoscopy
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 2 reports filed against devices carrying product code QNP. 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. The latest reports, in the reporter’s words:
28 July 2026 · Malfunction · Endoscopy CAD system · SHIRAKAWA OLYMPUS CO., LTD. · report 3002808148-2026-25724
29 August 2024 · Malfunction · PENTAX · HOYA CORPORATION PENTAX TOKYO OFFICE · report 9610877-2024-00082
COVER OF THE NEW SAS-M10 MONITOR SMOKED DURING SWITCH ON THE FIRST TIME 08-AUG-2024_WE ASKED FOR FURTHER INFORMATION AND PICTURES NO FURTHER INFORMATION. TEH MONITOR WAS SWITCHED OFF AND SEND BACK TO PENTAX MEDICAL EMEA FOR REPLACEMENT. THIS EVENT OCCURRED AT THE TIME OF INSTALLATION. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, […]
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 QNP, in Gastroenterology-Urology, from Magentiq Eye LTD, or cleared 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.