K203719 is an FDA 510(k) clearance for the IntraSight Mobile. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on January 19, 2021, 29 days after receiving the submission on December 21, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K203719 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2020 |
| Decision Date | January 19, 2021 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | IYO — System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |