Cleared Traditional

MODIFICATION TO AURORA MRI SYSTEM (K073425) - FDA 510(k) Clearance

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

K073425 · Aurora Imaging Technology, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
288d
Days
Class 2
Risk

K073425 is an FDA 510(k) clearance for the MODIFICATION TO AURORA MRI SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Aurora Imaging Technology, Inc. (North Andover, US). The FDA issued a Cleared decision on September 16, 2008 after a review of 288 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 Aurora Imaging Technology, Inc. devices

Submission Details

510(k) Number K073425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2007
Decision Date September 16, 2008
Days to Decision 288 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
181d slower than avg
Panel avg: 107d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 475
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K073425.
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
MAGNETOM VERIO
K072237 · Siemens Medical Solutions USA, Inc. · Oct 2007
MAGNETOM ESSENZA
K071925 · Siemens Medical Solutions USA, Inc. · Aug 2007
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K053009 · GE Medical Systems · Nov 2005