Cleared Traditional

K001303 - BREAST IMMOBILIZATION DEVICE MR-BY 160

K001303 is the FDA 510(k) clearance for BREAST IMMOBILIZATION DEVICE MR-BY 160 by Mri Devices Corp.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K001303 · Mri Devices Corp. · Radiology device
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Jun 2000
Decision
57d
Days
Class 2
Risk

K001303 is an FDA 510(k) clearance for the BREAST IMMOBILIZATION DEVICE MR-BY 160. 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 June 20, 2000 after a review of 57 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 Mri Devices Corp. devices

Submission Details

510(k) Number K001303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2000
Decision Date June 20, 2000
Days to Decision 57 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
50d faster than avg
Panel avg: 107d · This submission: 57d
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 311
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K001303.
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
HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA
K001713 · Mri Devices Corp. · Jun 2000
HI-RES 9000 PHASED ARRAY CAROTID COIL
K001210 · Usa Instruments, Inc. · Jun 2000
SYNERGY HEAD/NECK COIL
K001331 · Philips Medical Systems North America, Inc. · Jun 2000