Cleared Traditional

MRP-20: SUPPL R/F COIL HS/MR QUADRATURE HEAD COIL (K903204) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903204 · Summit World Trade Corp. · Radiology device
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Sep 1990
Decision
49d
Days
Class 2
Risk

K903204 is an FDA 510(k) clearance for the MRP-20: SUPPL R/F COIL HS/MR QUADRATURE HEAD COIL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Summit World Trade Corp. (Hudson, US). The FDA issued a Cleared decision on September 7, 1990 after a review of 49 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 Summit World Trade Corp. devices

Submission Details

510(k) Number K903204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1990
Decision Date September 07, 1990
Days to Decision 49 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
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 - LNH System, Nuclear Magnetic Resonance Imaging

All 485
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K903204.
MAGNETIC RESONANCE DIAGNOSTIC DEVICE-OR 41 MAGNET
K903527 · Siemens Medical Solutions USA, Inc. · Sep 1990
TEMPOROMANDIBULAR JOINT (TMJ) COIL
K902217 · Siemens Medical Solutions USA, Inc. · Sep 1990
GE QUADRATURE T/L SPINE SURF COIL, M1085AP/M1285AP
K902663 · General Electric Co. · Sep 1990
VISTA MR 2055 HP SYSTEM
K903048 · Philips Medical Systems (Cleveland), Inc. · Aug 1990
TESLACON (MAGNETIC RESONANCE DIAGNOSTIC DEVICE)
K902933 · General Electric Co. · Aug 1990
MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL
K901952 · Siemens Medical Solutions USA, Inc. · Aug 1990