Cleared Traditional

K081118 - NORAS MR-BI320-PA 1.5T

K081118 is an FDA 510(k) clearance for NORAS MR-BI320-PA 1.5T, 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 11-day FDA review.

K081118 · Noras Mri Products GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
11d
Days
Class 2
Risk

K081118 is an FDA 510(k) clearance for the NORAS MR-BI320-PA 1.5T. 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 May 2, 2008 after a review of 11 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 - K081118

510(k) Number K081118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2008
Decision Date May 02, 2008
Days to Decision 11 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 107d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Sud America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MOS Coil, Magnetic Resonance, Specialty

All 479
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K081118.
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