Cleared Traditional

K990550 - 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM

K990550 is an FDA 510(k) clearance for 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM, manufactured by Ge Medical Systems, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K990550 · Ge Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
78d
Days
Class 2
Risk

K990550 is an FDA 510(k) clearance for the 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Ge Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on May 11, 1999 after a review of 78 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, Inc. devices

FDA 510(k) Submission Details - K990550

510(k) Number K990550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1999
Decision Date May 11, 1999
Days to Decision 78 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
29d faster than avg
Panel avg: 107d · This submission: 78d
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 K990550.
IPASS BOLUS TRACKING
K992412 · Philips Medical Systems (Cleveland), Inc. · Aug 1999
HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM
K991652 · Siemens Corp. · Aug 1999
EXCELART
K990620 · Toshiba America Mri, Inc. · May 1999
OPART
K990260 · Toshiba America Mri, Inc. · Apr 1999
FLEXART,FLEXART/HYPER, VISART, VISART/HYPER
K983110 · Toshiba America Mri, Inc. · Feb 1999
FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR
K984221 · Siemens Corp. · Feb 1999