Cleared Traditional

K083166 - SPECIALTY COILS FOR THE MAGNETOM ESSENZA

K083166 is an FDA 510(k) clearance for SPECIALTY COILS FOR THE MAGNETOM ESSENZA, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K083166 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
78d
Days
Class 2
Risk

K083166 is an FDA 510(k) clearance for the SPECIALTY COILS FOR THE MAGNETOM ESSENZA. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on January 13, 2009 after a review of 78 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K083166

510(k) Number K083166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2008
Decision Date January 13, 2009
Days to Decision 78 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 107d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 490
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K083166.
SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64
K090267 · Midwest Rf, LLC · Mar 2009
NEONATE HEAD AND BODY COILS
K083541 · Advanced Imaging Research, Inc. · Feb 2009
NORAS CPC MULTIFUNCTIONAL COIL
K083578 · Noras Mri Products GmbH · Jan 2009
TT1 GENERAL PURPOSE COIL
K083434 · Tursiop Technologies, LLC · Dec 2008
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)
K083086 · Hitachi Medical Systems America, Inc. · Dec 2008
16CH AI BREAST COILS 1.5 T AND 3 T
K083255 · Rapid Biomedical GmbH · Nov 2008
K083166 · SPECIALTY COILS FOR THE MAGNETOM ESSENZA
Download PDF FDA Summary Siemens Medical Solut…