Cleared Traditional

K233652 - Contour Hand/Wrist (Q7000232)

K233652 is an FDA 510(k) clearance for Contour Hand/Wrist (Q7000232), manufactured by Quality Electrodynamics. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K233652 · Quality Electrodynamics · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
94d
Days
Class 2
Risk

K233652 is an FDA 510(k) clearance for the Contour Hand/Wrist (Q7000232). Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Quality Electrodynamics (Mayfield Heights, US). The FDA issued a Cleared decision on February 16, 2024 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Quality Electrodynamics devices

FDA 510(k) Submission Details - K233652

510(k) Number K233652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 107d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOS Device Classification - Class 2, Special Controls

Product Code MOS Coil, Magnetic Resonance, Specialty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MOS Coil, Magnetic Resonance, Specialty

All 312
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K233652.
dS Wrist coil 8ch 1.5T
K243033 · Philips Medical Systems Nederland B.V. · Oct 2024
dS FootAnkle Coil 8ch 1.5T
K242096 · Philips Medical Systems Nederland B.V. · Aug 2024
iLoop Interventional Coil 0.55T
K241069 · Noras Mri Products GmbH · Jun 2024
Contour Shoulder
K233656 · Quality Electrodynamics · Feb 2024
Smart Fit Knee 3.0T
K233600 · Philips Healthcare (Suzhou) Co., Ltd. · Feb 2024
InkSpace Imaging Small Body Array
K233444 · Inkspace Imaging, Inc. · Jan 2024