Cleared Special

3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL (K032538) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032538 · Usa Instruments, Inc. · Radiology device
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Sep 2003
Decision
25d
Days
Class 2
Risk

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.

View all Usa Instruments, Inc. devices

Submission Details

510(k) Number K032538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2003
Decision Date September 12, 2003
Days to Decision 25 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 92
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K032538.
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