Cleared Traditional

MODEL #QBC-17, 17CM. QUADRATURE BREAST COIL (K924653) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924653 · Mri Devices Corp. · Radiology device
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Dec 1992
Decision
100d
Days
Class 2
Risk

K924653 is an FDA 510(k) clearance for the MODEL #QBC-17, 17CM. QUADRATURE BREAST COIL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Mri Devices Corp. (Hartland, US). The FDA issued a Cleared decision on December 24, 1992 after a review of 100 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 Mri Devices Corp. devices

Submission Details

510(k) Number K924653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1992
Decision Date December 24, 1992
Days to Decision 100 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 107d · This submission: 100d
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 475
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K924653.
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
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K924479 · Siemens Medical Solutions USA, Inc. · Dec 1992
MAGNETIC RESONANCE DIAG DEVICE ACCESS APPLIC PKG
K924426 · Siemens Medical Solutions USA, Inc. · 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