Cleared Traditional

QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER (K951681) - FDA 510(k) Clearance

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

K951681 · Fonar Corp. · Radiology device
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Nov 1995
Decision
212d
Days
Class 2
Risk

K951681 is an FDA 510(k) clearance for the QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Fonar Corp. (Melville, US). The FDA issued a Cleared decision on November 9, 1995 after a review of 212 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 Fonar Corp. devices

Submission Details

510(k) Number K951681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1995
Decision Date November 09, 1995
Days to Decision 212 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 107d · This submission: 212d
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 K951681.
SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM
K942604 · GE Medical Systems · Nov 1995
CLINICAL PROTON SPECTROSCOPY OPTION
K951650 · Siemens Medical Solutions USA, Inc. · Nov 1995
ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION
K954355 · General Electric Co. · Nov 1995
MAGNETOM VISION (PROJECT 016)
K945517 · Siemens Medical Solutions USA, Inc. · Oct 1995
OUTLOOK
K945827 · Philips Medical Systems (Cleveland), Inc. · Sep 1995
MAGNETOM VISION (PROJECT 016)
K945779 · Siemens Medical Solutions USA, Inc. · Aug 1995