Gastroenterology-Urology · De Novo · 2021
GI Genius
Cosmo Artificial Intelligence - AI, LTD. Granted by FDA on 9 April 2021 under submission DEN200055, product code QNP (gastrointesinal lesion software detection system). What FDA's record says, in FDA's words.
Device record · DEN200055
- Device. GI GeniusDEVICE
- Company. Cosmo Artificial Intelligence - AI, LTDCOMPANY
- Decision. 9 April 2021, De NovoDECISION
- Panel. Gastroenterology-UrologyPANEL
- Product code. QNP, Gastrointesinal Lesion Software Detection SystemCODE
- Regulation. 21 CFR 876.1520, Class IIREG
- Source. FDA database entry · decision document (26 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.
. There is also uncertainty regarding the performance with different clinicians. The study included six endoscopists in Italy with ADR values between 25-40%. It is unknown if the study results would have been impacted if more endoscopists had been included, if the endoscopists were based in the US, or if the endoscopists had ADR values that were above or below 25-40%. Another area of uncertainty is the long-term usage of AI software devices, and the potential for overreliance on lesion detection software leading to errors in treatment and diagnosis, rather than the intended use of the device as an aid to clinicians. Related to the primary and secondary endpoints, although changes in ADR have been linked in the clinical literature to clinical outcomes, the impact of differences in APC and PPA on clinical outcomes is unknown. Furthermore, some clinically significant lesions, such as serrated lesions, did not occur with sufficient frequency in the study to draw conclusions about the performance of the GI Genius at detecting those lesions; the performance of the GI Genius at detection of non-adenoma clinically significant lesions is uncertain. There were also few videos in the standalone performance testing used with some models of video processors; the low sample sizes with those video processors is another source of uncertainty.
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
- 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 Cosmo Artificial Intelligence - AI, LTD, or granted in 2021. 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.