Cleared Traditional

K961525 - ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)

K961525 is an FDA 510(k) clearance for ARRAY OPEN BREAST COIL (MODEL OBC-63 PA), manufactured by Mri Devices Corp.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K961525 · Mri Devices Corp. · Radiology device
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Sep 1996
Decision
136d
Days
Class 2
Risk

K961525 is an FDA 510(k) clearance for the ARRAY OPEN BREAST COIL (MODEL OBC-63 PA). 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 September 5, 1996 after a review of 136 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 Mri Devices Corp. devices

FDA 510(k) Submission Details - K961525

510(k) Number K961525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1996
Decision Date September 05, 1996
Days to Decision 136 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 slower than avg
Panel avg: 107d · This submission: 136d
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 432
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K961525.
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL
K964854 · Medrad, Inc. · Feb 1997
GE STERILE DISPOSABLE EQUIPMENT COIL COVER
K964141 · Contour Fabricators, Inc. · Jan 1997
PHASED ARRAY SHOULDER COIL
K963356 · Philips Medical Systems (Cleveland), Inc. · Nov 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 1.5T QUAD C-SPINE SURFACE COIL
K954952 · Medrad, Inc. · Mar 1996