Cleared Traditional

Contour Hand/Wrist (Q7000232)

K233652 · Quality Electrodynamics · Radiology
Feb 2024
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K233652 is an FDA 510(k) clearance for the Contour Hand/Wrist (Q7000232), a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Quality Electrodynamics (Mayfield Heights, US). The FDA issued a Cleared decision on February 16, 2024, 94 days after receiving the submission on November 14, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K233652 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2023
Decision Date February 16, 2024
Days to Decision 94 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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