K190805 is an FDA 510(k) clearance for the PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL. This device is classified as a Endoscope, Accessories, Image Post-processing For Color Enhancement (Class II - Special Controls, product code PEA).
Submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on December 20, 2019, 266 days after receiving the submission on March 29, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. Alternative Mode Of Visualization Using Image Post-processing Algorithms Of The Received White Light Image For Color Enhancement..
| 510(k) Number | K190805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2019 |
| Decision Date | December 20, 2019 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PEA — Endoscope, Accessories, Image Post-processing For Color Enhancement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Alternative Mode Of Visualization Using Image Post-processing Algorithms Of The Received White Light Image For Color Enhancement. |