Cleared Special

K050621 - NVA-127-8-A NEUROVASCULAR ARRAY COIL

K050621 is an FDA 510(k) clearance for NVA-127-8-A NEUROVASCULAR ARRAY COIL, 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 28-day FDA review.

K050621 · Mri Devices Corporation · Radiology device
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Apr 2005
Decision
28d
Days
Class 2
Risk

K050621 is an FDA 510(k) clearance for the NVA-127-8-A NEUROVASCULAR ARRAY COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Mri Devices Corporation (Pewaukee, US). The FDA issued a Cleared decision on April 7, 2005 after a review of 28 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 Mri Devices Corporation devices

FDA 510(k) Submission Details - K050621

510(k) Number K050621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2005
Decision Date April 07, 2005
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
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 368
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K050621.
QD KNEE/FOOT COIL, MODEL MJQJ-147A
K051763 · Toshiba America Medical Systems, In.C · Jul 2005
OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
K050728 · Usa Instruments, Inc. · Jun 2005
3.0T PROSTATE IMAGING SYSTEM
K051349 · Medrad, Inc. · Jun 2005
AIRIS ELITE RAPID BODY COIL
K050307 · Hitachi Medical Systems America, Inc. · Feb 2005
13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA
K042718 · Siemens Medi Cal Solutions, Inc. · Nov 2004
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
K042617 · Siemens Medical Solutions USA, Inc. · Nov 2004