Cleared Traditional

MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE (K925286) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

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 K925286.
1.5T EDGE AND 1.0T VISTA SYSTEMS
K931544 · Philips Medical Systems (Cleveland), Inc. · Nov 1993
0.5T ASSET SYSTEM
K933835 · Philips Medical Systems (Cleveland), Inc. · Nov 1993
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K932344 · Siemens Medical Solutions USA, Inc. · Oct 1993
EDGE SYSTEM
K932693 · Philips Medical Systems (Cleveland), Inc. · Oct 1993
MODIFIED BODY HELMHOLTZ COIL
K930811 · Siemens Medical Solutions USA, Inc. · Sep 1993
MAG RESON DIAG DEVI ACCESS CIR POLAR(CP) HEAD COIL
K932374 · Siemens Medical Solutions USA, Inc. · Sep 1993