Cleared Traditional

K101949 - PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601

K101949 is an FDA 510(k) clearance for PEDIATRIC BODY-CARDIAC COIL, 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 16-day FDA review.

K101949 · Shanghai Chenguang Medical Technologies Co, Ltd. · Radiology device
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Jul 2010
Decision
16d
Days
Class 2
Risk

K101949 is an FDA 510(k) clearance for the PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601. 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 July 28, 2010 after a review of 16 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 Shanghai Chenguang Medical Technologies Co, Ltd. devices

FDA 510(k) Submission Details - K101949

510(k) Number K101949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2010
Decision Date July 28, 2010
Days to Decision 16 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
91d faster than avg
Panel avg: 107d · This submission: 16d
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 338
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