Cleared Traditional

K130692 - M2 WRIST 2 MRI SYSTEM

K130692 is an FDA 510(k) clearance for M2 WRIST 2 MRI SYSTEM, manufactured by Aspect Imaging, Ltd.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K130692 · Aspect Imaging, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
307d
Days
Class 2
Risk

K130692 is an FDA 510(k) clearance for the M2 WRIST 2 MRI SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Aspect Imaging, Ltd. (Somerset, US). The FDA issued a Cleared decision on January 14, 2014 after a review of 307 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

FDA 510(k) Submission Details - K130692

510(k) Number K130692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2013
Decision Date January 14, 2014
Days to Decision 307 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
200d slower than avg
Panel avg: 107d · This submission: 307d
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 872
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K130692.
MR ELASTOGRAPHY
K140666 · Philips Medical Systems Nederland B.V. · Jun 2014
MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE
K140253 · Siemens Medical Solutions USA, Inc. · Mar 2014
MDIXON-QUANT
K133526 · Philips Medical Systems Nederland B.V. · Feb 2014
G-SCAN BRIO
K133490 · Esaote, S.P.A. · Dec 2013
S-SCAN
K131996 · Esaote, S.P.A. · Dec 2013
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A
K133435 · Siemens Medical Solutions USA, Inc. · Dec 2013