Cleared Traditional

K953595 - MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY

K953595 is an FDA 510(k) clearance for MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K953595 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
88d
Days
Class 2
Risk

K953595 is an FDA 510(k) clearance for the MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on October 27, 1995 after a review of 88 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 devices

FDA 510(k) Submission Details - K953595

510(k) Number K953595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1995
Decision Date October 27, 1995
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
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 K953595.
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MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL
K954190 · Medical Advances, Inc. · Nov 1995
MODEL 445SI-64 & 445SI-42A: QUARDRATURE WRIST COIL
K952944 · Medical Advances, Inc. · Aug 1995
MODEL 410SI-64 SHOULDER LOOP PAIR, SMALL & LARGEM NIDEK 410SI-42A SHOULDER LOOP PAIR, SMALL & LARGE
K950966 · Medical Advances, Inc. · Jul 1995