EW10-EC02 Endoscopy Support Program
FDA 510(k) K260567 · Fujifilm Corporation
510(k) numberK260567
Submission
- Device name
- EW10-EC02 Endoscopy Support Program
- Applicant
- Fujifilm Corporation
Ashigarakami-Gun, JP - Received
- February 19, 2026
- Decision date
- August 7, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QNP – Gastrointesinal Lesion Software Detection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1520
- Specialty
- Gastroenterology, Urology
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.
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| K252586 | CaddieQNP · Special | Odin Medical Limited | 09/12/2025SE |
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Questions and answers
When was EW10-EC02 Endoscopy Support Program cleared by the FDA?
EW10-EC02 Endoscopy Support Program (K260567) received a 510(k) decision of Substantially Equivalent on August 7, 2026, 169 days after the submission was received.
What is the product code of K260567?
The FDA product code is QNP – Gastrointesinal Lesion Software Detection System, a Class II (moderate risk) device regulated under 21 CFR 876.1520.