Cleared Traditional

MODEL 311GE-64: WHOLE VOLUME NECK COIL (K914535) - FDA 510(k) Clearance

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

K914535 · Medical Advances, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
47d
Days
Class 2
Risk

K914535 is an FDA 510(k) clearance for the MODEL 311GE-64: WHOLE VOLUME NECK COIL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Medical Advances, Inc. (Milwaukee, US). The FDA issued a Cleared decision on November 27, 1991 after a review of 47 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 Medical Advances, Inc. devices

Submission Details

510(k) Number K914535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1991
Decision Date November 27, 1991
Days to Decision 47 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 107d · This submission: 47d
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 475
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K914535.
MAGNETIC RESONANE DIAGNOSTIC DEVICE ACCESSORY
K915395 · Siemens Medical Solutions USA, Inc. · Jan 1992
ADVANTAGE V.S. CT/MR RAD DIAGNOSTIC WORKSTATION
K913770 · General Electric Co. · Dec 1991
MAGNETOM 42 SP,63 SP,IMPACT
K915112 · Siemens Medical Solutions USA, Inc. · Dec 1991
RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM
K913869 · Siemens Medical Solutions USA, Inc. · Nov 1991
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K913475 · GE Medical Systems · Oct 1991
SIGNA ADVANTAGE 0.5T MAGNETIC RESONANCE SYSTEM
K912539 · GE Medical Systems · Sep 1991