510(k) K253714

IntraSight Plus by Philips Image Guided Therapy Corporation — Product Code IYO

K253714 is an FDA 510(k) premarket notification submitted by Philips Image Guided Therapy Corporation for the device "IntraSight Plus". The FDA issued a decision of Substantially Equivalent on February 24, 2026. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Philips Image Guided Therapy Corporation has at least 3 other 510(k) clearances on record.