K230751 is an FDA 510(k) clearance for the EW10-EC02 Endoscopy Support Program. This device is classified as a Gastrointesinal Lesion Software Detection System (Class II - Special Controls, product code QNP).
Submitted by Fujifilm Corporation (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on December 15, 2023, 273 days after receiving the submission on March 17, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1520. 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..
| 510(k) Number | K230751 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2023 |
| Decision Date | December 15, 2023 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QNP — Gastrointesinal Lesion Software Detection System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1520 |
| Definition | 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. |