Cleared Special

K032576 - BIOPSY BREAST COIL

K032576 is the FDA 510(k) clearance for BIOPSY BREAST COIL by Mri Devices Corp.. It is a Class 2 Radiology device (product code MOS) cleared through the Special 510(k) pathway after a 64-day FDA review.

K032576 · Mri Devices Corp. · Radiology device
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Oct 2003
Decision
64d
Days
Class 2
Risk

K032576 is an FDA 510(k) clearance for the BIOPSY BREAST COIL, MODEL BBC. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Mri Devices Corp. (Waukesha, US). The FDA issued a Cleared decision on October 23, 2003 after a review of 64 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mri Devices Corp. devices

Submission Details

510(k) Number K032576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2003
Decision Date October 23, 2003
Days to Decision 64 days
Submission Type Special
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
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

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 311
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K032576.
PELVIC ARRAY COIL
K033753 · Usa Instruments, Inc. · Dec 2003
MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS
K033567 · Mri Devices Corp. · Nov 2003
MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
K033353 · Usa Instruments, Inc. · Nov 2003
KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL
K033151 · Mri Devices Corp. · Oct 2003
HAC-12 AND HAC-30 HEAD ARRAY COIL
K033152 · Mri Devices Corp. · Oct 2003
HRK-63-8 KNEE ARRAY COIL
K032633 · Mri Devices Corp. · Sep 2003