Cleared Traditional

16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)

K244054 · Quality Electrodynamics · Radiology
Feb 2025
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K244054 is an FDA 510(k) clearance for the 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247), a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Quality Electrodynamics (Mayfield Village, US). The FDA issued a Cleared decision on February 28, 2025, 59 days after receiving the submission on December 31, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K244054 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 2024
Decision Date February 28, 2025
Days to Decision 59 days
Submission Type Traditional
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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