Cleared Traditional

K920543 - MRI OE 1.5 SI

K920543 is an FDA 510(k) clearance for MRI OE 1.5 SI, manufactured by Otsuka Electronics. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K920543 · Otsuka Electronics · Radiology device
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Jul 1992
Decision
156d
Days
Class 2
Risk

K920543 is an FDA 510(k) clearance for the MRI OE 1.5 SI. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Otsuka Electronics (Fort Collins, US). The FDA issued a Cleared decision on July 10, 1992 after a review of 156 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 Otsuka Electronics devices

FDA 510(k) Submission Details - K920543

510(k) Number K920543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1992
Decision Date July 10, 1992
Days to Decision 156 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
49d slower than avg
Panel avg: 107d · This submission: 156d
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 1005
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K920543.
VISTA HPQ SYSTEM
K921881 · Philips Medical Systems (Cleveland), Inc. · Jul 1992
MRT-50A QD SPINE COIL
K921720 · Toshiba America Mri, Inc. · Jul 1992
MRT-150 QD KNEE COIL
K920096 · Toshiba America Mri, Inc. · Jul 1992
COILS FOR RX4000 & RX5000 MRI SYSTEMS
K920254 · Resonex, Inc. · Jun 1992
VISTA HP/HPQ SYSTEM
K921609 · Philips Medical Systems (Cleveland), Inc. · Jun 1992
ACCESS QD HEAD COIL
K920098 · Toshiba America Mri, Inc. · Jun 1992