ME-APDS; MAGENTIQ-COLO
Magentiq Eye LTD is listed for ME-APDS; MAGENTIQ-COLO (K223473). The FDA list gives July 25, 2023 as the date of the final decision. The lead panel is Gastroenterology-Urology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QNP as “Gastrointesinal Lesion Software Detection System”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” 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/pmn.cfm?ID=K223473
- Date of final decision
- July 25, 2023
- Company on the FDA list
- Magentiq Eye LTD
- Lead panel
- Gastroenterology-Urology
- Primary product code
- QNP
- openFDA device name for the code
- Gastrointesinal Lesion Software Detection System
- Device class
- 2
- Regulation number
- 876.1520
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary
Product-code text from openFDA
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.