Cleared Special

K002539 - OBC-096 BREAST ARRAY COIL

K002539 is the FDA 510(k) clearance for OBC-096 BREAST ARRAY COIL by Mri Devices Corp.. It is a Class 2 Radiology device (product code MOS) cleared through the Special 510(k) pathway after a 14-day FDA review.

K002539 · Mri Devices Corp. · Radiology device
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Aug 2000
Decision
14d
Days
Class 2
Risk

K002539 is an FDA 510(k) clearance for the OBC-096 BREAST ARRAY COIL. 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 August 30, 2000 after a review of 14 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 K002539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2000
Decision Date August 30, 2000
Days to Decision 14 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
93d faster than avg
Panel avg: 107d · This submission: 14d
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 K002539.
VISION 9000 PHASED ARRAY TORSO COIL
K002482 · Usa Instruments, Inc. · Oct 2000
OBC-63 MEBREAST ARRAY COIL
K002602 · Mri Devices Corp. · Sep 2000
NEUROVASCULAR ARRAY COIL
K001946 · Ge Medical Systems, Inc. · Aug 2000
MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL
K001870 · Usa Instruments, Inc. · Aug 2000
HAC-300 HEAD ARRAY COIL
K001944 · Mri Devices Corp. · Aug 2000
LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
K001582 · Usa Instruments, Inc. · Jul 2000