Cleared Traditional

GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR (K910817) - FDA 510(k) Clearance

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

K910817 · General Electric Co. · Radiology device
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Apr 1991
Decision
56d
Days
Class 2
Risk

K910817 is an FDA 510(k) clearance for the GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on April 23, 1991 after a review of 56 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 General Electric Co. devices

Submission Details

510(k) Number K910817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1991
Decision Date April 23, 1991
Days to Decision 56 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 107d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 430
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K910817.
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VISTA HPQ SYSTEM
K910715 · Philips Medical Systems (Cleveland), Inc. · Jun 1991
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K905366 · Siemens Medical Solutions USA, Inc. · Feb 1991
MAGNETIC RESONANCE DIAG. DEV. SPECIAL PURPOSE COIL
K905615 · Siemens Medical Solutions USA, Inc. · Feb 1991