Cleared Special

Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System

K251397 · Philips Medical Systems Nederland B.V. · Radiology
Jun 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K251397 is an FDA 510(k) clearance for the Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System, 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 June 4, 2025, 29 days after receiving the submission on May 6, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K251397 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2025
Decision Date June 04, 2025
Days to Decision 29 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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