510(k) K230751
K230751 is an FDA 510(k) premarket notification submitted by Fujifilm Corporation for the device "EW10-EC02 Endoscopy Support Program". The FDA issued a decision of Substantially Equivalent on December 15, 2023. The device falls under product code QNP (Gastrointesinal Lesion Software Detection System), a Class II device regulated under 21 CFR 876.1520. Fujifilm Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2023
- Date Received
- March 17, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointesinal Lesion Software Detection System
- Device Class
- Class II
- Regulation Number
- 876.1520
- Review Panel
- GU
- Submission Type
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.