Cleared Traditional

Contour Shoulder (K233656) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233656 · Quality Electrodynamics · Radiology device
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Optimized for regulatory review, auditing and printing
Feb 2024
Decision
93d
Days
Class 2
Risk

K233656 is an FDA 510(k) clearance for the Contour Shoulder. 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 15, 2024 after a review of 93 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

Submission Details

510(k) Number K233656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2023
Decision Date February 15, 2024
Days to Decision 93 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
14d faster than avg
Panel avg: 107d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 95
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K233656.
dS FootAnkle Coil 8ch 1.5T
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iLoop Interventional Coil 0.55T
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Contour Hand/Wrist (Q7000232)
K233652 · Quality Electrodynamics · Feb 2024
Smart Fit Knee 3.0T
K233600 · Philips Healthcare (Suzhou) Co., Ltd. · Feb 2024
InkSpace Imaging Small Body Array
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16 Breast Coil
K233348 · Philips Medical System Nederlands B.V. · Oct 2023