Cleared Traditional

K981190 - HIGH IMPEDANCE CARDIAC GATING CABLE

K981190 is an FDA 510(k) clearance for HIGH IMPEDANCE CARDIAC GATING CABLE, 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 89-day FDA review.

K981190 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
89d
Days
Class 2
Risk

K981190 is an FDA 510(k) clearance for the HIGH IMPEDANCE CARDIAC GATING CABLE. 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 June 30, 1998 after a review of 89 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 - K981190

510(k) Number K981190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1998
Decision Date June 30, 1998
Days to Decision 89 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
18d faster than avg
Panel avg: 107d · This submission: 89d
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 K981190.
ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS
K983327 · Siemens Medical Solutions USA, Inc. · Oct 1998
IMAGE POST-PROCESSING TECHNIQUES
K980831 · Philips Medical Systems (Cleveland), Inc. · Aug 1998
OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE
K981475 · Toshiba America Mri, Inc. · Jul 1998
HAMMERSMITH ENDOCAVITARY COILS
K981410 · Philips Medical Systems (Cleveland), Inc. · Jun 1998
PHILIPS GYROSCAN NT RELEASE 6 SERIES
K980645 · Philips Medical Systems North America, Inc. · May 1998
DIFFUSION PACKAGE / GYROSCAN NT
K973658 · Philips Medical Systems North America, Inc. · May 1998