Cleared Traditional

K083255 - 16CH AI BREAST COILS 1.5 T AND 3 T

K083255 is an FDA 510(k) clearance for 16CH AI BREAST COILS 1.5 T AND 3 T, manufactured by Rapid Biomedical GmbH. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K083255 · Rapid Biomedical GmbH · Radiology device
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Nov 2008
Decision
17d
Days
Class 2
Risk

K083255 is an FDA 510(k) clearance for the 16CH AI BREAST COILS 1.5 T AND 3 T. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Rapid Biomedical GmbH (Rimpar, DE). The FDA issued a Cleared decision on November 21, 2008 after a review of 17 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Rapid Biomedical GmbH devices

FDA 510(k) Submission Details - K083255

510(k) Number K083255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2008
Decision Date November 21, 2008
Days to Decision 17 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
90d faster than avg
Panel avg: 107d · This submission: 17d
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 Rheinland of North America, Inc.
TAMAS BORSAI

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 483
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K083255.
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