Cleared Traditional

POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM (K884369) - FDA 510(k) Clearance

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

K884369 · General Electric Co. · Radiology device
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Nov 1988
Decision
41d
Days
Class 2
Risk

K884369 is an FDA 510(k) clearance for the POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM. 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 November 28, 1988 after a review of 41 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 K884369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1988
Decision Date November 28, 1988
Days to Decision 41 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
66d faster than avg
Panel avg: 107d · This submission: 41d
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 K884369.
MAGNETOM 42 SP AND MAGNETOM 63 SP
K883898 · Siemens Medical Solutions USA, Inc. · Jan 1989
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K884484 · Siemens Medical Solutions USA, Inc. · Jan 1989
GE MR MAX SYSTEM
K883547 · General Electric Co. · Nov 1988
MAGNETOM (M, H, 42, 63) SEQUENCES
K884062 · Siemens Medical Solutions USA, Inc. · Nov 1988
CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL
K883872 · Siemens Medical Solutions USA, Inc. · Nov 1988
VISTA MR 2055 HP SYSTEM
K883994 · Philips Medical Systems (Cleveland), Inc. · Nov 1988