Cleared Traditional

K093044 - OASIS MRI SYSTEM (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093044 · Hitachi Medical Systems America, Inc. · Radiology device
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Mar 2010
Decision
167d
Days
Class 2
Risk

K093044 is an FDA 510(k) clearance for the OASIS MRI SYSTEM. Classified as System, Nuclear Magnetic Resonance Spectroscopic (product code LNI), Class II - Special Controls.

Submitted by Hitachi Medical Systems America, Inc. (Twinsburg, US). The FDA issued a Cleared decision on March 16, 2010 after a review of 167 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.

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Submission Details

510(k) Number K093044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2009
Decision Date March 16, 2010
Days to Decision 167 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
60d slower than avg
Panel avg: 107d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNI System, Nuclear Magnetic Resonance Spectroscopic
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.