Cleared Traditional

K180123 - Breast BI 7 MR Coil 1.5T Mammavention

K180123 is an FDA 510(k) clearance for Breast BI 7 MR Coil 1.5T Mammavention, manufactured by Noras Mri Products GmbH. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K180123 · Noras Mri Products GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
31d
Days
Class 2
Risk

K180123 is an FDA 510(k) clearance for the Breast BI 7 MR Coil 1.5T Mammavention. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Noras Mri Products GmbH (Hoechberg, DE). The FDA issued a Cleared decision on February 16, 2018 after a review of 31 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 Noras Mri Products GmbH devices

FDA 510(k) Submission Details - K180123

510(k) Number K180123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2018
Decision Date February 16, 2018
Days to Decision 31 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 107d · This submission: 31d
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 312
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