Cleared Traditional

K190524 - MRopen 0.5 T

K190524 is an FDA 510(k) clearance for MRopen 0.5 T, manufactured by Asg Superconductors S.P.A.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K190524 · Asg Superconductors S.P.A. · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2019
Decision
119d
Days
Class 2
Risk

K190524 is an FDA 510(k) clearance for the MRopen 0.5 T. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Asg Superconductors S.P.A. (Genova, IT). The FDA issued a Cleared decision on July 1, 2019 after a review of 119 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 Asg Superconductors S.P.A. devices

FDA 510(k) Submission Details - K190524

510(k) Number K190524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2019
Decision Date July 01, 2019
Days to Decision 119 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
12d slower than avg
Panel avg: 107d · This submission: 119d
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.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 840
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