Cleared Special

K061930 - INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY

K061930 is an FDA 510(k) clearance for INDOMITABLE MAGNETIC RESONANCE IMAGING ..., manufactured by Fonar Corp.. The device is a Class 2 Radiology device with product code LNH cleared through the Special 510(k) pathway after a 21-day FDA review.

K061930 · Fonar Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
21d
Days
Class 2
Risk

K061930 is an FDA 510(k) clearance for the INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY. 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 July 28, 2006 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K061930

510(k) Number K061930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2006
Decision Date July 28, 2006
Days to Decision 21 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 1107
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K061930.
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DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA
K061429 · Esaote, S.P.A. · Jul 2006
BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0
K061255 · Kyron Clinical Imaging, Inc. · Jun 2006
MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035
K061132 · Neusoft Medical Systems Co., Ltd. · May 2006
K061930 · INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY
Download PDF FDA Summary Fonar Corp.