K243479 is an FDA 510(k) clearance for the EchoGuide (Version 1). This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Sonavex, Inc. (Baltimore, US). The FDA issued a Cleared decision on April 23, 2025, 166 days after receiving the submission on November 8, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K243479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2024 |
| Decision Date | April 23, 2025 |
| Days to Decision | 166 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |