Cleared Traditional

K954952 - MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL

K954952 is an FDA 510(k) clearance for MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFAC..., manufactured by Medrad, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K954952 · Medrad, Inc. · Radiology device
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Mar 1996
Decision
135d
Days
Class 2
Risk

K954952 is an FDA 510(k) clearance for the MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Medrad, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on March 13, 1996 after a review of 135 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medrad, Inc. devices

FDA 510(k) Submission Details - K954952

510(k) Number K954952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1995
Decision Date March 13, 1996
Days to Decision 135 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 107d · This submission: 135d
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 427
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K954952.
ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)
K961525 · Mri Devices Corp. · Sep 1996
MINI FLEX COIL
K961628 · W.L. Gore & Associates, Inc. · Sep 1996
FLEXART QD HEAD/NECK COIL
K961391 · Toshiba America Mri, Inc. · Jul 1996
MEDRAD/HITACHI BREAST IMAGING SURFACE COIL
K955626 · Medrad, Inc. · Feb 1996
MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL
K954190 · Medical Advances, Inc. · Nov 1995
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K953595 · GE Medical Systems · Oct 1995