Cleared Special

K042103 - NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL

K042103 is an FDA 510(k) clearance for NVA-63-8-A AND NVA-63-16-A NEUROVASCULA..., manufactured by Mri Devices Corporation. The device is a Class 2 Radiology device with product code MOS cleared through the Special 510(k) pathway after a 12-day FDA review.

K042103 · Mri Devices Corporation · Radiology device
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Aug 2004
Decision
12d
Days
Class 2
Risk

K042103 is an FDA 510(k) clearance for the NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Mri Devices Corporation (Waukesha, US). The FDA issued a Cleared decision on August 16, 2004 after a review of 12 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.

FDA 510(k) Submission Details - K042103

510(k) Number K042103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2004
Decision Date August 16, 2004
Days to Decision 12 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

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 K042103.
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K041921 · Ge Medical Systems, LLC · Jul 2004
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K041481 · Mri Devices Corp. · Jul 2004
K042103 · NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL
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