Cleared Special

dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T

K254190 · Philips Medical Systems Nederland B.V. · Radiology
Jan 2026
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K254190 is an FDA 510(k) clearance for the dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T, a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on January 14, 2026, 22 days after receiving the submission on December 23, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K254190 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2025
Decision Date January 14, 2026
Days to Decision 22 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MOS — Coil, Magnetic Resonance, Specialty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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