K031143 is an FDA 510(k) clearance for ALPHA 5000 WRIST COIL, manufactured by Usa Instruments, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 49-day FDA review.
K031143 is an FDA 510(k) clearance for the ALPHA 5000 WRIST COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.
Submitted by Usa Instruments, Inc. (Aurora, US). The FDA issued a Cleared decision on May 29, 2003 after a review of 49 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.
| Product Code | MOS Coil, Magnetic Resonance, Specialty |
| Device Class | Class 2 - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |
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.
Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.