Cleared Traditional

AURORA IMAGING SYSTEM (K950837) - FDA 510(k) Clearance

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

K950837 · Advanced Mammography Systems, Inc. · Radiology device
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Feb 1996
Decision
367d
Days
Class 2
Risk

K950837 is an FDA 510(k) clearance for the AURORA IMAGING SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Advanced Mammography Systems, Inc. (Wilmington, US). The FDA issued a Cleared decision on February 26, 1996 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Advanced Mammography Systems, Inc. devices

Submission Details

510(k) Number K950837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1995
Decision Date February 26, 1996
Days to Decision 367 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
260d slower than avg
Panel avg: 107d · This submission: 367d
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 485
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K950837.
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K954353 · General Electric Co. · Apr 1996
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K954354 · General Electric Co. · Apr 1996
AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM
K955811 · Siemens Medical Solutions USA, Inc. · Mar 1996
EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS
K954646 · Philips Medical Systems (Cleveland), Inc. · Jan 1996
SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM
K942604 · GE Medical Systems · Nov 1995
CLINICAL PROTON SPECTROSCOPY OPTION
K951650 · Siemens Medical Solutions USA, Inc. · Nov 1995