Cleared Special

Ingenia Elition R5.7.1 SP4 MR Systems

K232030 · Philips Medical Systems Nederland B.V. · Radiology
Aug 2023
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K232030 is an FDA 510(k) clearance for the Ingenia Elition R5.7.1 SP4 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 August 2, 2023, 26 days after receiving the submission on July 7, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K232030 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2023
Decision Date August 02, 2023
Days to Decision 26 days
Submission Type Special
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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