Cleared Traditional

MRT-150 QD KNEE COIL (K920096) - FDA 510(k) Clearance

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

K920096 · Toshiba America Mri, Inc. · Radiology device
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Jul 1992
Decision
184d
Days
Class 2
Risk

K920096 is an FDA 510(k) clearance for the MRT-150 QD KNEE 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 July 10, 1992 after a review of 184 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

Submission Details

510(k) Number K920096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1992
Decision Date July 10, 1992
Days to Decision 184 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
77d slower than avg
Panel avg: 107d · This submission: 184d
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 K920096.
GENERAL PURPOSE FLEX COIL
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K920714 · Philips Medical Systems (Cleveland), Inc. · Aug 1992
VISTA HPQ SYSTEM
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VISTA HP/HPQ SYSTEM
K921609 · Philips Medical Systems (Cleveland), Inc. · Jun 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K920094 · Siemens Medical Solutions USA, Inc. · May 1992
MAGNETOM 63SP
K921098 · Siemens Medical Solutions USA, Inc. · May 1992