Cleared Traditional

K071611 - NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL

K071611 is an FDA 510(k) clearance for NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL, manufactured by Neocoil. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K071611 · Neocoil · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
15d
Days
Class 2
Risk

K071611 is an FDA 510(k) clearance for the NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Neocoil (Pewaukee, US). The FDA issued a Cleared decision on June 28, 2007 after a review of 15 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neocoil devices

FDA 510(k) Submission Details - K071611

510(k) Number K071611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2007
Decision Date June 28, 2007
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 341
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K071611.
OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120
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NORAS OR HEAD HOLDER
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ECHELON MR-RCC-150 CARDIAC COIL
K063513 · Hitachi Medical Systems America, Inc. · Dec 2006
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K063342 · Medrad, Inc. · Nov 2006