K253714 is an FDA 510(k) clearance for the IntraSight Plus. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Philips Image Guided Therapy Corporation (Colorado Springs, US). The FDA issued a Cleared decision on February 24, 2026, 92 days after receiving the submission on November 24, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K253714 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2025 |
| Decision Date | February 24, 2026 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| 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 |