Cleared Special

K052497 - NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A

K052497 is an FDA 510(k) clearance for NEUROVASCULAR ARRAY COIL, manufactured by Invivo Corp.. The device is a Class 2 Radiology device with product code MOS cleared through the Special 510(k) pathway after a 30-day FDA review.

K052497 · Invivo Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
30d
Days
Class 2
Risk

K052497 is an FDA 510(k) clearance for the NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Invivo Corp. (Pewaukee, US). The FDA issued a Cleared decision on October 12, 2005 after a review of 30 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 - K052497

510(k) Number K052497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2005
Decision Date October 12, 2005
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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 K052497.
USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY
K052916 · Usa Instruments, Inc. · Nov 2005
MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE
K052704 · Invivo Corp. · Nov 2005
MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS
K052827 · Medrad, Inc. · Nov 2005
1.5T 12 CHANNEL BODY ARRAY
K052584 · Usa Instruments, Inc. · Oct 2005
1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
K052621 · Usa Instruments, Inc. · Oct 2005
3T HD BREAST ARRAY
K052585 · Usa Instruments, Inc. · Oct 2005
K052497 · NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A
Download PDF Invivo Corp.