Cleared Traditional

K092962 - CAROTID COIL 5000004901

K092962 is an FDA 510(k) clearance for CAROTID COIL 5000004901, manufactured by Shanghai Chenguang Medical Technologies Co, Ltd.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K092962 · Shanghai Chenguang Medical Technologies Co, Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
14d
Days
Class 2
Risk

K092962 is an FDA 510(k) clearance for the CAROTID COIL 5000004901. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Shanghai Chenguang Medical Technologies Co, Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 9, 2009 after a review of 14 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.

FDA 510(k) Submission Details - K092962

510(k) Number K092962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2009
Decision Date October 09, 2009
Days to Decision 14 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
93d faster than avg
Panel avg: 107d · This submission: 14d
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 489
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K092962.
SHOULDER SPEEDER COIL
K093667 · Quality Electrodynamics · Jan 2010
NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH
K093693 · Noras Mri Products GmbH · Jan 2010
3.0T 16 CHANNEL HEAD NECK SPINE COIL
K093348 · Ge Healthcare Coils (Usa Instruments, Inc.) · Nov 2009
1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484
K091902 · Invivo · Aug 2009
NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230
K091546 · Noras Mri Products GmbH · Jun 2009
TXRX 1.5T CP HEAD COIL
K091114 · Quality Electrodynamics · May 2009
K092962 · CAROTID COIL 5000004901
Download PDF FDA Summary Shanghai Chenguang Me…