Cleared Traditional

K113145 - ECHELON OVAL MRI SYSTEM

K113145 is an FDA 510(k) clearance for ECHELON OVAL MRI SYSTEM, manufactured by Hitachi Medical Systems America, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K113145 · Hitachi Medical Systems America, Inc. · Radiology device
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May 2012
Decision
189d
Days
Class 2
Risk

K113145 is an FDA 510(k) clearance for the ECHELON OVAL MRI SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Hitachi Medical Systems America, Inc. (Twinsburg, US). The FDA issued a Cleared decision on May 1, 2012 after a review of 189 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.

View all Hitachi Medical Systems America, Inc. devices

FDA 510(k) Submission Details - K113145

510(k) Number K113145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2011
Decision Date May 01, 2012
Days to Decision 189 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 107d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
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.

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All 965
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