Cleared Special

Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems

K251808 · Philips Medical Systems Nederland B.V. · Radiology
Jul 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K251808 is an FDA 510(k) clearance for the Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 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 July 11, 2025, 29 days after receiving the submission on June 12, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K251808 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2025
Decision Date July 11, 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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