Cleared Special

K091546 - NORAS OR HEAD COIL 3T

K091546 is an FDA 510(k) clearance for NORAS OR HEAD COIL 3T, manufactured by Noras Mri Products GmbH. 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.

K091546 · Noras Mri Products GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
28d
Days
Class 2
Risk

K091546 is an FDA 510(k) clearance for the NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Noras Mri Products GmbH (Hoechberg, DE). The FDA issued a Cleared decision on June 24, 2009 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 Noras Mri Products GmbH devices

FDA 510(k) Submission Details - K091546

510(k) Number K091546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2009
Decision Date June 24, 2009
Days to Decision 28 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
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 313
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K091546.
S-SCAN, MODEL 9800020010
K100670 · Esaote, S.P.A. · Apr 2010
1.5T AND 3.0T GENERAL PURPOSE FLEX COILS
K093842 · Invivo Corporation · Mar 2010
1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL
K093284 · Invivo Corporation · Feb 2010
SPECIALTY COILS FOR THE MAGNETOM ESSENZA
K083166 · Siemens Medical Solutions USA, Inc. · Jan 2009
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)
K083086 · Hitachi Medical Systems America, Inc. · Dec 2008
ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
K083014 · Toshiba America Medical Systems, In.C · Oct 2008