Cleared Abbreviated

K063513 - ECHELON MR-RCC-150 CARDIAC COIL

K063513 is an FDA 510(k) clearance for ECHELON MR-RCC-150 CARDIAC 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 21-day FDA review.

K063513 · Hitachi Medical Systems America, Inc. · Radiology device
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Dec 2006
Decision
21d
Days
Class 2
Risk

K063513 is an FDA 510(k) clearance for the ECHELON MR-RCC-150 CARDIAC 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 December 12, 2006 after a review of 21 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 - K063513

510(k) Number K063513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2006
Decision Date December 12, 2006
Days to Decision 21 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
86d faster than avg
Panel avg: 107d · This submission: 21d
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
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