Cleared Traditional

K923010 - MAGNETIC RESONANCE DIAGNOSTIC DEVICE

K923010 is the FDA 510(k) clearance for MAGNETIC RESONANCE DIAGNOSTIC DEVICE 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 64-day FDA review.

K923010 · Hitachi Medical Systems America, Inc. · Radiology device
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Aug 1992
Decision
64d
Days
Class 2
Risk

K923010 is an FDA 510(k) clearance for the MAGNETIC RESONANCE DIAGNOSTIC DEVICE. 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 August 25, 1992 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hitachi Medical Systems America, Inc. devices

Submission Details

510(k) Number K923010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1992
Decision Date August 25, 1992
Days to Decision 64 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
43d faster than avg
Panel avg: 107d · This submission: 64d
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 K923010.
VISTA HPQ SYSTEM
K923615 · Philips Medical Systems (Cleveland), Inc. · Oct 1992
GENERAL PURPOSE FLEX COIL
K923264 · General Electric Co. · Sep 1992
QD WHOLE BODY COIL, MRT-150A
K922798 · Toshiba America Mri, Inc. · Sep 1992
VISTA HPQ SYSTEM
K920714 · Philips Medical Systems (Cleveland), Inc. · Aug 1992
MRT-50
K921413 · Toshiba America Mri, Inc. · Aug 1992
3D TOF ANGIOGRAPHY MEASURING FUNCTION
K920441 · Hitachi Medical Systems America, Inc. · Jul 1992