Cleared Traditional

K151074 - Magnetic Reasonance Imaging System

K151074 is an FDA 510(k) clearance for Magnetic Reasonance Imaging System, manufactured by Jiangsu Magspin Instrument Co.,Ltd. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K151074 · Jiangsu Magspin Instrument Co.,Ltd · Radiology device
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Dec 2015
Decision
244d
Days
Class 2
Risk

K151074 is an FDA 510(k) clearance for the Magnetic Reasonance Imaging System. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Jiangsu Magspin Instrument Co.,Ltd (Kunshan, CN). The FDA issued a Cleared decision on December 22, 2015 after a review of 244 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.

View all Jiangsu Magspin Instrument Co.,Ltd devices

FDA 510(k) Submission Details - K151074

510(k) Number K151074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2015
Decision Date December 22, 2015
Days to Decision 244 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
137d slower than avg
Panel avg: 107d · This submission: 244d
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 K151074.
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K151579 · Siemens Medical Solutions USA, Inc. · Sep 2015