Cleared Traditional

K920095 - MRT-50 MULTIVIEW COIL

K920095 is the FDA 510(k) clearance for MRT-50 MULTIVIEW COIL by Toshiba America Mri, Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K920095 · Toshiba America Mri, Inc. · Radiology device
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Apr 1992
Decision
111d
Days
Class 2
Risk

K920095 is an FDA 510(k) clearance for the MRT-50 MULTIVIEW 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 April 28, 1992 after a review of 111 days - within the typical 510(k) review window.

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 K920095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1992
Decision Date April 28, 1992
Days to Decision 111 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 107d · This submission: 111d
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 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K920095.
ACCESS QD HEAD COIL
K920098 · Toshiba America Mri, 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
MRT-50 FLEXIBLE BODY COIL
K920126 · Toshiba America Mri, Inc. · Apr 1992
MRT-50 QD HEAD COIL
K920097 · Toshiba America Mri, Inc. · Mar 1992
MRT-50 SPINE COIL
K920125 · Toshiba America Mri, Inc. · Mar 1992