Gastroenterology-Urology · 510(k) · 2023
GI Genius System 100 and GI Genius System 200
Cosmo Artificial Intelligence - AI Ltd. Cleared by FDA on 19 May 2023 under submission K231143, product code QNP (gastrointesinal lesion software detection system). What FDA's record says, in FDA's words.
Device record · K231143
- Device. GI Genius System 100 and GI Genius System 200DEVICE
- Company. Cosmo Artificial Intelligence - AI Ltd (IE)COMPANY
- Decision. 19 May 2023, 510(k), substantially equivalent (special review); received 21 April 2023DECISION
- Panel. Gastroenterology-UrologyPANEL
- Product code. QNP, Gastrointesinal Lesion Software Detection SystemCODE
- Regulation. 21 CFR 876.1520, Class IIREG
- Source. FDA database entry · decision document (8 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 GI Genius System is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white-light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.
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 namedendoscopy
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
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 Cosmo Artificial Intelligence - AI 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.