Cleared Traditional

K071154 - SUPERSTAR 0.35T MRI SYSTEM

K071154 is an FDA 510(k) clearance for SUPERSTAR 0.35T MRI SYSTEM, manufactured by Neusoft Medical Systems Co., Ltd.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K071154 · Neusoft Medical Systems Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
15d
Days
Class 2
Risk

K071154 is an FDA 510(k) clearance for the SUPERSTAR 0.35T MRI SYSTEM. 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 10, 2007 after a review of 15 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

FDA 510(k) Submission Details - K071154

510(k) Number K071154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2007
Decision Date May 10, 2007
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K071154.
MAGNETOM VERIO
K072237 · Siemens Medical Solutions USA, Inc. · Oct 2007
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K072279 · Hitachi Medical Systems America, Inc. · Sep 2007
MAGNETOM ESSENZA
K071925 · Siemens Medical Solutions USA, Inc. · Aug 2007
ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
K063559 · Philips Medical Systems · Jan 2007
EXCELART VANTAGE ATLAS, MODEL MRT-1503
K063361 · Toshiba America Medical Systems, In.C · Nov 2006
S-SCAN MRI SYSTEM
K063207 · Esaote, S.P.A. · Nov 2006