Cleared Traditional

K924426 - MAGNETIC RESONANCE DIAG DEVICE ACCESS A...

K924426 is the FDA 510(k) clearance for MAGNETIC RESONANCE DIAG DEVICE ACCESS A... by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K924426 · Siemens Medical Solutions USA, Inc. · Radiology device
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Dec 1992
Decision
108d
Days
Class 2
Risk

K924426 is an FDA 510(k) clearance for the MAGNETIC RESONANCE DIAG DEVICE ACCESS APPLIC PKG. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on December 18, 1992 after a review of 108 days - within the typical 510(k) review window.

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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K924426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date December 18, 1992
Days to Decision 108 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
1d slower than avg
Panel avg: 107d · This submission: 108d
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 812
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K924426.
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
SIGNA BREAST COIL AND ARRAY ACCESSORY
K923025 · GE Medical Systems · Nov 1992
GENERAL PURPOSE FLEX COIL, CATALOG NUMBER M1685GP
K924349 · General Electric Co. · Nov 1992
MRT-35(TM)
K921940 · Toshiba America Mri, Inc. · Nov 1992