This software 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 endoscopy…
This software 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 endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. This software is used with standard White Light Imaging (WLI) and Linked Color Imaging (LCI) endoscopy imaging. This software is not intended to replace clinical decision making.
Who Else Makes It
Registered in Sichuan.
Record
Regulatory record for Fujifilm | Listed by | Fujifilm Corporation, Japan |
| FDA product code | QNP |
| Device type | Gastrointesinal Lesion Software Detection System |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1520 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K230751 |
| Record published | 2024-02-16 |
| Record revised | 2024-06-11 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 90 % RH; Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 90 % RH |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.