Cleared Traditional

SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL (K983139) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983139 · GE Medical Systems · Radiology device
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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

Submission Details

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.

Device Classification

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 94
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K983139.
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
K003613 · GE Medical Systems · Apr 2001
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
K003946 · GE Medical Systems · Feb 2001
CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM
K994315 · Siemens Medical Solutions USA, Inc. · Feb 2000
PHASED ARRAY FLEXIBLE CARDIAC COIL
K984588 · Philips Medical Systems (Cleveland), Inc. · Feb 1999
SIGNA PROFILE SMALL HEAD COIL
K982972 · GE Medical Systems · Nov 1998
OUTLOOK LARGE PHASED ARRAY NECK COIL
K981959 · Philips Medical Systems (Cleveland), Inc. · Jul 1998