Cleared Traditional

K923423 - QUADATURE HEAD/NECK/VASCULAR COIL

K923423 is an FDA 510(k) clearance for QUADATURE HEAD/NECK/VASCULAR COIL, manufactured by Medical Advances, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K923423 · Medical Advances, Inc. · Radiology device
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Dec 1992
Decision
164d
Days
Class 2
Risk

K923423 is an FDA 510(k) clearance for the QUADATURE HEAD/NECK/VASCULAR COIL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Medical Advances, Inc. (Milwaukee, US). The FDA issued a Cleared decision on December 24, 1992 after a review of 164 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 Medical Advances, Inc. devices

FDA 510(k) Submission Details - K923423

510(k) Number K923423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1992
Decision Date December 24, 1992
Days to Decision 164 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 107d · This submission: 164d
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 997
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K923423.
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
MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL
K923140 · Hitachi Medical Systems America, 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
MAGNETIC RESONANCE DIAG DEVICE ACCESS APPLIC PKG
K924426 · Siemens Medical Solutions USA, Inc. · Dec 1992