K211326 is an FDA 510(k) clearance for the EndoScreener. This device is classified as a Gastrointesinal Lesion Software Detection System (Class II - Special Controls, product code QNP).
Submitted by Chengdu Wision Medical Device Co., Ltd. (Chengdu, CN). The FDA issued a Cleared decision on November 19, 2021, 203 days after receiving the submission on April 30, 2021.
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 | K211326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2021 |
| Decision Date | November 19, 2021 |
| Days to Decision | 203 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. |