Cleared Traditional

K955626 - MEDRAD/HITACHI BREAST IMAGING SURFACE COIL

K955626 is the FDA 510(k) clearance for MEDRAD/HITACHI BREAST IMAGING SURFACE COIL by Medrad, Inc.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K955626 · Medrad, Inc. · Radiology device
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Feb 1996
Decision
78d
Days
Class 2
Risk

K955626 is an FDA 510(k) clearance for the MEDRAD/HITACHI BREAST IMAGING 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 February 27, 1996 after a review of 78 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 Medrad, Inc. devices

Submission Details

510(k) Number K955626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1995
Decision Date February 27, 1996
Days to Decision 78 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
29d faster than avg
Panel avg: 107d · This submission: 78d
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 K955626.
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 1.5T QUAD C-SPINE SURFACE COIL
K954952 · Medrad, Inc. · Mar 1996
MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL
K954190 · Medical Advances, Inc. · Nov 1995
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K953595 · GE Medical Systems · Oct 1995
MODEL 445SI-64 & 445SI-42A: QUARDRATURE WRIST COIL
K952944 · Medical Advances, Inc. · Aug 1995