Cleared Abbreviated

K102748 - 31P/1H HEAD COIL 3T

Also marketed or referenced as:
23NA/1H HEAD COIL 3T 13C/1H HEAD COIL 3T

K102748 is an FDA 510(k) clearance for 31P/1H HEAD COIL 3T, manufactured by Rapid Biomedical GmbH. The device is a Class 2 Radiology device with product code MOS cleared through the Abbreviated 510(k) pathway after a 232-day FDA review.

K102748 · Rapid Biomedical GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
232d
Days
Class 2
Risk

K102748 is an FDA 510(k) clearance for the 31P/1H HEAD 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 May 13, 2011 after a review of 232 days - an extended review 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 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

FDA 510(k) Submission Details - K102748

510(k) Number K102748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2010
Decision Date May 13, 2011
Days to Decision 232 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
125d slower than avg
Panel avg: 107d · This submission: 232d
Pathway characteristics
Standards-based clearance path.

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 483
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K102748.
SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING
K103274 · Sentinelle Medical, Inc. · Aug 2011
SV DBS VRAIN ARRAY
K111259 · Midwest Rf, LLC · Jul 2011
4CH FLEX SPEEDER
K111251 · Toshiba Medical Systems Coporation, Japan · May 2011
FLEXIBLE CARDIAC COIL
K110487 · Lbds Holding Company · Apr 2011
ATAMA SYSTEM
K110411 · Monteris Medical, Inc. · Apr 2011
TEMPOROMANIBULAR COIL 15
K110373 · Esaote, S.P.A. · Apr 2011