Cleared Traditional

K253714 - IntraSight Plus

K253714 is an FDA 510(k) clearance for IntraSight Plus, manufactured by Philips Image Guided Therapy Corporation. The device is a Class 2 Cardiovascular device with product code IYO cleared through the Traditional 510(k) pathway after a 92-day FDA review.

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

K253714 is an FDA 510(k) clearance for the IntraSight Plus. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Philips Image Guided Therapy Corporation (Colorado Springs, US). The FDA issued a Cleared decision on February 24, 2026 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 892.1560 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Image Guided Therapy Corporation devices

FDA 510(k) Submission Details - K253714

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 448
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