Cleared Traditional

K925286 - MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE

K925286 is an FDA 510(k) clearance for MRT-150A MRI SYSTEM W/SUPER PERFORMANCE..., 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 352-day FDA review.

K925286 · Toshiba America Mri, Inc. · Radiology device
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Oct 1993
Decision
352d
Days
Class 2
Risk

K925286 is an FDA 510(k) clearance for the MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE. 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 7, 1993 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K925286

510(k) Number K925286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1992
Decision Date October 07, 1993
Days to Decision 352 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
245d slower than avg
Panel avg: 107d · This submission: 352d
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 K925286.
PHILIPS MRI BREAST COIL
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MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
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MRT-50A, MRT-150A
K926001 · Toshiba America Mri, Inc. · Oct 1993
GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0
K925985 · Elscint, Inc. · Oct 1993
MRINNERVU DISPOSABLE ENDORECTAL CERVIX COIL#BCR-15
K930779 · Medrad, Inc. · Oct 1993
ARTOSCAN
K931022 · Biosound, Inc. · Oct 1993