Cleared Traditional

K100141 - 14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA

K100141 is an FDA 510(k) clearance for 14-CHANNEL EXTREMITY COIL FOR MAGNETOM ..., 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 220-day FDA review.

K100141 · 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
Aug 2010
Decision
220d
Days
Class 2
Risk

K100141 is an FDA 510(k) clearance for the 14-CHANNEL EXTREMITY COIL FOR 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 August 27, 2010 after a review of 220 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K100141

510(k) Number K100141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2010
Decision Date August 27, 2010
Days to Decision 220 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
113d slower than avg
Panel avg: 107d · This submission: 220d
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
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K100141 · 14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
Download PDF FDA Summary Siemens Medical Solut…