Cleared Abbreviated

K102348 - 31P/1H DUAL TUNED SURFACE COIL 3T (FDA 510(k) Clearance)

Also includes:
23NA/ 1H DUAL TURNED SURFACE COIL 3T 13C /1H DUAL TURNED SURFACE COIL 3T

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K102348 · Rapid Biomedical GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
125d
Days
Class 2
Risk

K102348 is an FDA 510(k) clearance for the 31P/1H DUAL TUNED SURFACE COIL 3T. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Rapid Biomedical GmbH (Rimpar, Bavaria, DE). The FDA issued a Cleared decision on December 22, 2010 after a review of 125 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Rapid Biomedical GmbH devices

Submission Details

510(k) Number K102348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2010
Decision Date December 22, 2010
Days to Decision 125 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 107d · This submission: 125d
Pathway characteristics
Standards-based clearance path.

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

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