Cleared Traditional

IntraSight Plus

K253714 · Philips Image Guided Therapy Corporation · Cardiovascular
Feb 2026
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K253714 is an FDA 510(k) clearance for the IntraSight Plus, 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 review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K253714 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1560

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