Cleared Traditional

K050476 - CORDLESS COIL

K050476 is an FDA 510(k) clearance for CORDLESS COIL, manufactured by Siemens Medical Solution, Inc. USA. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K050476 · Siemens Medical Solution, Inc. USA · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
29d
Days
Class 2
Risk

K050476 is an FDA 510(k) clearance for the CORDLESS COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Siemens Medical Solution, Inc. USA (Malvern, US). The FDA issued a Cleared decision on March 25, 2005 after a review of 29 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.

View all Siemens Medical Solution, Inc. USA devices

FDA 510(k) Submission Details - K050476

510(k) Number K050476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2005
Decision Date March 25, 2005
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
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 368
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K050476.
QD KNEE/FOOT COIL, MODEL MJQJ-147A
K051763 · Toshiba America Medical Systems, In.C · Jul 2005
OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
K050728 · Usa Instruments, Inc. · Jun 2005
3.0T PROSTATE IMAGING SYSTEM
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AIRIS ELITE RAPID BODY COIL
K050307 · Hitachi Medical Systems America, Inc. · Feb 2005
13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA
K042718 · Siemens Medi Cal Solutions, Inc. · Nov 2004
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
K042617 · Siemens Medical Solutions USA, Inc. · Nov 2004