Cleared Traditional

ESTEEM 1.5T MRI SYSTEM (K972826) - FDA 510(k) Clearance

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

K972826 · Elscint Mr, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Oct 1997
Decision
78d
Days
Class 2
Risk

K972826 is an FDA 510(k) clearance for the ESTEEM 1.5T MRI SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Elscint Mr, Inc. (Fort Collins, US). The FDA issued a Cleared decision on October 15, 1997 after a review of 78 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 Elscint Mr, Inc. devices

Submission Details

510(k) Number K972826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1997
Decision Date October 15, 1997
Days to Decision 78 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
29d faster than avg
Panel avg: 107d · This submission: 78d
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 K972826.
DUFFUSION-WEIGHTED MR IMAGING PACKAGE
K974530 · Philips Medical Systems (Cleveland), Inc. · Feb 1998
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K972990 · GE Medical Systems · Feb 1998
CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT
K973799 · Siemens Medical Solutions USA, Inc. · Jan 1998
ASSET APOLLO
K971884 · Philips Medical Systems (Cleveland), Inc. · Aug 1997
MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)
K971684 · Siemens Medical Solutions USA, Inc. · Aug 1997
SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS
K971668 · GE Medical Systems · Jul 1997