K032538 is an FDA 510(k) clearance for 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR..., manufactured by Usa Instruments, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Special 510(k) pathway after a 25-day FDA review.
K032538 is an FDA 510(k) clearance for the 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY 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 September 12, 2003 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.
Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.
| 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.