Cleared Traditional

K172110 - ECHELON OVAL V6.0A MRI System

K172110 is the FDA 510(k) clearance for ECHELON OVAL V6.0A MRI System by Hitachi Healthcare Americas Corporation. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K172110 · Hitachi Healthcare Americas Corporation · Radiology device
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Jan 2018
Decision
182d
Days
Class 2
Risk

K172110 is an FDA 510(k) clearance for the ECHELON OVAL V6.0A MRI System. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Hitachi Healthcare Americas Corporation (Twinsburg, US). The FDA issued a Cleared decision on January 11, 2018 after a review of 182 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 Healthcare Americas Corporation devices

Submission Details

510(k) Number K172110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2017
Decision Date January 11, 2018
Days to Decision 182 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
75d slower than avg
Panel avg: 107d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 815
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