Cleared Traditional

K923140 - MRP-5000 AND 7000 BILATERAL/UNILATERAL ...

K923140 is the FDA 510(k) clearance for MRP-5000 AND 7000 BILATERAL/UNILATERAL ... by Hitachi Medical Systems America, Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K923140 · Hitachi Medical Systems America, Inc. · Radiology device
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Dec 1992
Decision
178d
Days
Class 2
Risk

K923140 is an FDA 510(k) clearance for the MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Hitachi Medical Systems America, Inc. (Twinsburg, US). The FDA issued a Cleared decision on December 24, 1992 after a review of 178 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 Hitachi Medical Systems America, Inc. devices

Submission Details

510(k) Number K923140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1992
Decision Date December 24, 1992
Days to Decision 178 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
71d slower than avg
Panel avg: 107d · This submission: 178d
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 K923140.
SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM
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MAG RES DIAG DEVI ACCESS CIR POLAR(CP) SPINE COIL
K924756 · Siemens Medical Solutions USA, Inc. · Dec 1992
VECTRA MAGNETIC RESONANCE SYSTEM
K921653 · General Electric Co. · Dec 1992
QUADATURE HEAD/NECK/VASCULAR COIL
K923423 · Medical Advances, Inc. · Dec 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K924479 · Siemens Medical Solutions USA, Inc. · Dec 1992
MODEL #QBC-17, 17CM. QUADRATURE BREAST COIL
K924653 · Mri Devices Corp. · Dec 1992