K231249 is an FDA 510(k) clearance for the PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL. 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 July 28, 2023, 88 days after receiving the submission on May 1, 2023.
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 | K231249 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2023 |
| Decision Date | July 28, 2023 |
| Days to Decision | 88 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. |