Cleared Traditional

K940364 - MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY

K940364 is the FDA 510(k) clearance for MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY by Medical Advances, Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K940364 · Medical Advances, Inc. · Radiology device
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Jun 1994
Decision
146d
Days
Class 2
Risk

K940364 is an FDA 510(k) clearance for the MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Medical Advances, Inc. (Milwaukee, US). The FDA issued a Cleared decision on June 21, 1994 after a review of 146 days - within the typical 510(k) review window.

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 Medical Advances, Inc. devices

Submission Details

510(k) Number K940364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1994
Decision Date June 21, 1994
Days to Decision 146 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 107d · This submission: 146d
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

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