Cleared Traditional

MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A (K082485) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082485 · Neusoft Medical Systems Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
12d
Days
Class 2
Risk

K082485 is an FDA 510(k) clearance for the MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A. 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 September 9, 2008 after a review of 12 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neusoft Medical Systems Co., Ltd. devices

Submission Details

510(k) Number K082485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2008
Decision Date September 09, 2008
Days to Decision 12 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

All 499
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K082485.
SYNGO BREVIS
K090038 · Siemens Medical Solutions USA, Inc. · Apr 2009
SYNGO MR B17
K082427 · Siemens Medical Solutions USA, Inc. · Nov 2008
MAGNETOM C!
K082331 · Siemens Medical Solutions USA, Inc. · Oct 2008
VANTAGE TITAN, MODEL MRT-1504/S3
K080038 · Toshiba America Medical Systems, In.C · Jan 2008
JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X
K073081 · Toshiba America Medical Systems, In.C · Nov 2007
MAGNETOM VERIO
K072237 · Siemens Medical Solutions USA, Inc. · Oct 2007