Cleared Special

K230972 - Ingenia Elition and MR 7700 MR Systems

K230972 is an FDA 510(k) clearance for Ingenia Elition and MR 7700 MR Systems, manufactured by Philips Medical Systems Nederland B.V.. The device is a Class 2 Radiology device with product code LNH cleared through the Special 510(k) pathway after a 23-day FDA review.

K230972 · Philips Medical Systems Nederland B.V. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
23d
Days
Class 2
Risk

K230972 is an FDA 510(k) clearance for the Ingenia Elition and MR 7700 MR Systems. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland B.V. (Best Noord-Brabant, NL). The FDA issued a Cleared decision on April 28, 2023 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K230972

510(k) Number K230972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2023
Decision Date April 28, 2023
Days to Decision 23 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

LNH Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 1109
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K230972.
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K230972 · Ingenia Elition and MR 7700 MR Systems
Download PDF FDA Summary Philips Medical Syste…