Cleared Traditional

K113281 - MRI SYTEMS

K113281 is an FDA 510(k) clearance for MRI SYTEMS, manufactured by Shenzhen Anke High-Tech Co., Ltd.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K113281 · Shenzhen Anke High-Tech Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
192d
Days
Class 2
Risk

K113281 is an FDA 510(k) clearance for the MRI SYTEMS. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Shenzhen Anke High-Tech Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on May 17, 2012 after a review of 192 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 Shenzhen Anke High-Tech Co., Ltd. devices

FDA 510(k) Submission Details - K113281

510(k) Number K113281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2011
Decision Date May 17, 2012
Days to Decision 192 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
85d slower than avg
Panel avg: 107d · This submission: 192d
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 Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 818
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K113281.
S-SCAN
K121650 · Esaote, S.P.A. · Jul 2012
VANTAGE TITAN
K120638 · Toshibamedical Systems Corporation · Jun 2012
VANTAGE TITAN 3T
K120487 · Toshibamedical Systems Corporation · May 2012
ECHELON OVAL MRI SYSTEM
K113145 · Hitachi Medical Systems America, Inc. · May 2012
SPEEDUP SOFTWARE OPTION
K120748 · Esaote, S.P.A. · May 2012
VANTAGE TITAN 3T
K113093 · Toshibamedical Systems Corporation · Jan 2012