Cleared Traditional

K961624 - FLEXART TMJ COIL

K961624 is an FDA 510(k) clearance for FLEXART TMJ COIL, manufactured by Toshiba America Mri, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K961624 · Toshiba America Mri, Inc. · Radiology device
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Oct 1996
Decision
175d
Days
Class 2
Risk

K961624 is an FDA 510(k) clearance for the FLEXART TMJ COIL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Toshiba America Mri, Inc. (S. San Francisco, US). The FDA issued a Cleared decision on October 18, 1996 after a review of 175 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 Toshiba America Mri, Inc. devices

FDA 510(k) Submission Details - K961624

510(k) Number K961624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1996
Decision Date October 18, 1996
Days to Decision 175 days
Submission Type Traditional
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
68d slower than avg
Panel avg: 107d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 997
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K961624.
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
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HELAX TMS BRACHYTHERAPY, VERSION 3.0
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OPART MRT-600
K962933 · Toshiba America Mri, Inc. · Oct 1996
ADVANTAGE WINDOWS TISSUE VOLUME OPTION
K963345 · GE Medical Systems · Oct 1996
IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS
K962927 · Siemens Medical Solutions USA, Inc. · Sep 1996
ESTEEM 1.5T MRI SYSTEM
K962677 · Elscint Mr, Inc. · Sep 1996