Cleared Traditional

K162549 - Lumify Ultrasound System

K162549 is the FDA 510(k) clearance for Lumify Ultrasound System by Philips Health Care. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K162549 · Philips Health Care · Radiology device
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Oct 2016
Decision
20d
Days
Class 2
Risk

K162549 is an FDA 510(k) clearance for the Lumify Ultrasound System. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Philips Health Care (Bothell, US). The FDA issued a Cleared decision on October 3, 2016 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Philips Health Care devices

Submission Details

510(k) Number K162549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2016
Decision Date October 03, 2016
Days to Decision 20 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 107d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 780
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K162549.
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