Cleared Traditional

K982772 - SIGNA PROFILE QUADRATURE THORACIC/LUMBA...

K982772 is an FDA 510(k) clearance for SIGNA PROFILE QUADRATURE THORACIC/LUMBA..., manufactured by Ge Medical Systems, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K982772 · Ge Medical Systems, Inc. · Radiology device
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Oct 1998
Decision
69d
Days
Class 2
Risk

K982772 is an FDA 510(k) clearance for the SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Ge Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on October 15, 1998 after a review of 69 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 - K982772

510(k) Number K982772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1998
Decision Date October 15, 1998
Days to Decision 69 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
38d faster than avg
Panel avg: 107d · This submission: 69d
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 K982772.
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K982916 · Medrad, Inc. · Oct 1998
PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64
K983222 · Medical Advances, Inc. · Oct 1998
MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY
K983109 · Medical Advances, Inc. · Oct 1998
QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D
K982496 · Medical Advances, Inc. · Sep 1998