Cleared Abbreviated

K062556 - ECHELON SHOULDER COIL

K062556 is an FDA 510(k) clearance for ECHELON SHOULDER COIL, manufactured by Hitachi Medical Systems America, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Abbreviated 510(k) pathway after a 36-day FDA review.

K062556 · Hitachi Medical Systems America, Inc. · Radiology device
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Oct 2006
Decision
36d
Days
Class 2
Risk

K062556 is an FDA 510(k) clearance for the ECHELON SHOULDER COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Hitachi Medical Systems America, Inc. (Twinsburg, US). The FDA issued a Cleared decision on October 5, 2006 after a review of 36 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Hitachi Medical Systems America, Inc. devices

FDA 510(k) Submission Details - K062556

510(k) Number K062556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2006
Decision Date October 05, 2006
Days to Decision 36 days
Submission Type Abbreviated
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
71d faster than avg
Panel avg: 107d · This submission: 36d
Pathway characteristics
Standards-based clearance path.

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 411
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K062556.
MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS
K063342 · Medrad, Inc. · Nov 2006
FLEX LOOP COIL SET 3T
K063373 · Siemens AG · Nov 2006
CTL-63 AND CTL-128 SPINE ARRAY COILS
K062767 · Invivo Corporation · Oct 2006
HHF1 ECHELON MULTI-PURPOSE COIL
K061950 · Hitachi Medical Systems America, Inc. · Aug 2006
MRGFUS GENERAL PURPOSE AND BREAST COIL
K061715 · Insightec Txsonics, Inc. · Jul 2006
CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16
K061952 · Invivo · Jul 2006