Cleared Abbreviated

Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems

K223458 · Philips Medical Systems Nederland B.V. · Radiology
Apr 2023
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K223458 is an FDA 510(k) clearance for the Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on April 6, 2023, 141 days after receiving the submission on November 16, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K223458 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2022
Decision Date April 06, 2023
Days to Decision 141 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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