Cleared Special

K061132 - MODIFICATION TO SUPEROPEN 0.35T

K061132 is an FDA 510(k) clearance for MODIFICATION TO SUPEROPEN 0.35T, manufactured by Neusoft Medical Systems Co., Ltd.. The device is a Class 2 Radiology device with product code LNH cleared through the Special 510(k) pathway after a 30-day FDA review.

K061132 · Neusoft Medical Systems Co., Ltd. · Radiology device
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May 2006
Decision
30d
Days
Class 2
Risk

K061132 is an FDA 510(k) clearance for the MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Neusoft Medical Systems Co., Ltd. (Shenyang, Liaoning, CN). The FDA issued a Cleared decision on May 24, 2006 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Neusoft Medical Systems Co., Ltd. devices

FDA 510(k) Submission Details - K061132

510(k) Number K061132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2006
Decision Date May 24, 2006
Days to Decision 30 days
Submission Type Special
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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K061132.
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