Cleared Traditional

K923423 - QUADATURE HEAD/NECK/VASCULAR COIL

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

K923423 · Medical Advances, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 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