Cleared Traditional

K983139 - SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECE...

K983139 is an FDA 510(k) clearance for SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECE..., manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K983139 · GE Medical Systems · Radiology device
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Optimized for regulatory review, auditing and printing
Feb 1999
Decision
164d
Days
Class 2
Risk

K983139 is an FDA 510(k) clearance for the SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on February 19, 1999 after a review of 164 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 - K983139

510(k) Number K983139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1998
Decision Date February 19, 1999
Days to Decision 164 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
57d slower than avg
Panel avg: 107d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOS Device Classification - Class 2, Special Controls

Product Code MOS Coil, Magnetic Resonance, Specialty
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 - MOS Coil, Magnetic Resonance, Specialty

All 312
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K983139.
LINEAR SHOULDER COIL, MODEL 414GE-09
K991115 · Medical Advances, Inc. · Jun 1999
EXTRA LARGE BODY COIL FOR OPART (MRT-600)
K991057 · Toshiba America Mri, Inc. · May 1999
OPART, MODEL MRT-600
K990007 · Toshiba America Mri, Inc. · Apr 1999
PHASED ARRAY FLEXIBLE CARDIAC COIL
K984588 · Philips Medical Systems (Cleveland), Inc. · Feb 1999
MEDRAD PHASED ARRAY NEUROVASCULAR COIL
K984257 · Medrad, Inc. · Jan 1999
MEDRAD QUADRATURE CTL ARRAY COIL
K984159 · Medrad, Inc. · Jan 1999