Cleared Special

dS Wrist coil 8ch 1.5T

K243033 · Philips Medical Systems Nederland B.V. · Radiology
Oct 2024
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K243033 is an FDA 510(k) clearance for the dS Wrist coil 8ch 1.5T, 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 October 18, 2024, 21 days after receiving the submission on September 27, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K243033 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2024
Decision Date October 18, 2024
Days to Decision 21 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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