Cleared Traditional

K903319 - MAGNETIC RESONANCE DIAGNOSTIC DEVICE

K903319 is an FDA 510(k) clearance for MAGNETIC RESONANCE DIAGNOSTIC DEVICE, 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 23-day FDA review.

K903319 · GE Medical Systems · Radiology device
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Aug 1990
Decision
23d
Days
Class 2
Risk

K903319 is an FDA 510(k) clearance for the MAGNETIC RESONANCE DIAGNOSTIC DEVICE. 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 August 17, 1990 after a review of 23 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all GE Medical Systems devices

FDA 510(k) Submission Details - K903319

510(k) Number K903319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1990
Decision Date August 17, 1990
Days to Decision 23 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
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 K903319.
MEGA 4 MAGNETIC RESONANCE IMAGING SYSTEM
K902044 · Instrumentarium Imaging, Inc. · Aug 1990
TESLACON (MAGNETIC RESONANCE DIAGNOSTIC DEVICE)
K902933 · General Electric Co. · Aug 1990
MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL
K901952 · Siemens Medical Solutions USA, Inc. · Aug 1990
PROSTATE PROBE SURFACE COIL, CATALOG #BPX-15
K901888 · Medrad, Inc. · Aug 1990
LARGE FLEXIBLE BODY COIL
K902314 · Toshiba America Mri, Inc. · Aug 1990
SOFTWARE RELEASE 4.2P, ACCESS(TM)
K902310 · Toshiba America Mri, Inc. · Aug 1990