Cleared Special

K040348 - MODIFICATION TO HNC-127-INT NEUROVASCUL...

K040348 is the FDA 510(k) clearance for MODIFICATION TO HNC-127-INT NEUROVASCUL... by Mri Devices Corp.. It is a Class 2 Radiology device (product code MOS) cleared through the Special 510(k) pathway after a 26-day FDA review.

K040348 · Mri Devices Corp. · Radiology device
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Mar 2004
Decision
26d
Days
Class 2
Risk

K040348 is an FDA 510(k) clearance for the MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Mri Devices Corp. (Waukesha, US). The FDA issued a Cleared decision on March 9, 2004 after a review of 26 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 Corp. devices

Submission Details

510(k) Number K040348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2004
Decision Date March 09, 2004
Days to Decision 26 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
81d faster than avg
Panel avg: 107d · This submission: 26d
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 311
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K040348.
MODEL BBC-127 BIOPSY BREAST COIL
K041481 · Mri Devices Corp. · Jul 2004
QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT
K041487 · Usa Instruments, Inc. · Jun 2004
MODIFICATION TO E-SCAN XQ MRI SYSTEM
K041145 · Esaote, S.P.A. · May 2004
MODIFICATION TO HRW-127 WRIST ARRAY COIL
K040349 · Mri Devices Corp. · Mar 2004
QSC-127-INT SHOULDER ARRAY COIL SET
K040288 · Mri Devices Corp. · Mar 2004
SYNERGY SPINE ARRAY COIL
K033662 · Philips Medical Systems, Inc. · Feb 2004