Cleared Traditional

K923025 - SIGNA BREAST COIL AND ARRAY ACCESSORY

K923025 is an FDA 510(k) clearance for SIGNA BREAST COIL AND ARRAY ACCESSORY, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K923025 · GE Medical Systems · Radiology device
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Nov 1992
Decision
157d
Days
Class 2
Risk

K923025 is an FDA 510(k) clearance for the SIGNA BREAST COIL AND ARRAY ACCESSORY. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on November 27, 1992 after a review of 157 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 GE Medical Systems devices

FDA 510(k) Submission Details - K923025

510(k) Number K923025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1992
Decision Date November 27, 1992
Days to Decision 157 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
50d slower than avg
Panel avg: 107d · This submission: 157d
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 840
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K923025.
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
GENERAL PURPOSE FLEX COIL, CATALOG NUMBER M1685GP
K924349 · General Electric Co. · Nov 1992
MRT-35(TM)
K921940 · Toshiba America Mri, Inc. · Nov 1992
SIGNA ADVANTAGE 0.5T MAG RESON SYS-FAST ACQUIS OPT
K921941 · General Electric Co. · Nov 1992