Cleared Abbreviated

K153324 - Ingenia 1.5T and Ingenia 1.5T S R5.2

K153324 is the FDA 510(k) clearance for Ingenia 1.5T and Ingenia 1.5T S R5.2 by Philips Medical Systems Nederlands B.V.. It is a Class 2 Radiology device (product code LNH) cleared through the Abbreviated 510(k) pathway after a 125-day FDA review.

K153324 · Philips Medical Systems Nederlands B.V. · Radiology device
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Mar 2016
Decision
125d
Days
Class 2
Risk

K153324 is an FDA 510(k) clearance for the Ingenia 1.5T and Ingenia 1.5T S R5.2. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Philips Medical Systems Nederlands B.V. (Best Noord-Brabant, NL). The FDA issued a Cleared decision on March 22, 2016 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Philips Medical Systems Nederlands B.V. devices

Submission Details

510(k) Number K153324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2015
Decision Date March 22, 2016
Days to Decision 125 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 107d · This submission: 125d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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.

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