Cleared Traditional

K954952 - MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFAC...

K954952 is the FDA 510(k) clearance for MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFAC... by Medrad, Inc.. It is a Class 2 Radiology device (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

Submission Details

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.

Device Classification

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 300
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