Cleared Traditional

MAGNETIC RESONANCE DIAGNOSTIC DEVICE MRP-20 (K894016) - FDA 510(k) Clearance

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

K894016 · Summit World Trade Corp. · Radiology device
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Nov 1989
Decision
169d
Days
Class 2
Risk

K894016 is an FDA 510(k) clearance for the MAGNETIC RESONANCE DIAGNOSTIC DEVICE MRP-20. 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 November 22, 1989 after a review of 169 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Summit World Trade Corp. devices

Submission Details

510(k) Number K894016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1989
Decision Date November 22, 1989
Days to Decision 169 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 107d · This submission: 169d
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 K894016.
VISTA HPQ SYSTEM, VISTA MR 2055 HP SYSTEM
K900064 · Philips Medical Systems (Cleveland), Inc. · Mar 1990
VISTA MR 2055 HP SYSTEM
K896508 · Philips Medical Systems (Cleveland), Inc. · Jan 1990
MAGNETOM M, H, 42, 63, 42 SP AND 63 SP
K895966 · Siemens Medical Solutions USA, Inc. · Nov 1989
GE MR MAX SYSTEM
K895794 · GE Medical Systems · Nov 1989
VISTA MR 2055 HP SYSTEM
K895151 · Philips Medical Systems (Cleveland), Inc. · Oct 1989
ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 42
K895221 · Siemens Medical Solutions USA, Inc. · Oct 1989