Cleared Traditional

K162651 - Breast BI 7 MR Coil Mammavention 3T

K162651 is an FDA 510(k) clearance for Breast BI 7 MR Coil Mammavention 3T, manufactured by Moras Mri Products GmbH. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K162651 · Moras Mri Products GmbH · Radiology device
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Jan 2017
Decision
117d
Days
Class 2
Risk

K162651 is an FDA 510(k) clearance for the Breast BI 7 MR Coil Mammavention 3T. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Moras Mri Products GmbH (Hoechberg, DE). The FDA issued a Cleared decision on January 18, 2017 after a review of 117 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 Moras Mri Products GmbH devices

FDA 510(k) Submission Details - K162651

510(k) Number K162651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2016
Decision Date January 18, 2017
Days to Decision 117 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 107d · This submission: 117d
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 329
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K162651.
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