Cleared Traditional

K120701 - M2 WRIST MRI SYSTEM

K120701 is the FDA 510(k) clearance for M2 WRIST MRI SYSTEM by Aspect Imaging, Ltd.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K120701 · Aspect Imaging, Ltd. · Radiology device
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Feb 2013
Decision
337d
Days
Class 2
Risk

K120701 is an FDA 510(k) clearance for the M2 WRIST MRI SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Aspect Imaging, Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on February 7, 2013 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Aspect Imaging, Ltd. devices

Submission Details

510(k) Number K120701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2012
Decision Date February 07, 2013
Days to Decision 337 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
230d slower than avg
Panel avg: 107d · This submission: 337d
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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