Cleared Traditional

K901818 - ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 63

K901818 is an FDA 510(k) clearance for ADD'L SOFTWARE VERSION D2 FOR MAGNETOM ..., manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K901818 · Siemens Medical Solutions USA, Inc. · Radiology device
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May 1990
Decision
30d
Days
Class 2
Risk

K901818 is an FDA 510(k) clearance for the ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 63. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on May 23, 1990 after a review of 30 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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K901818

510(k) Number K901818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1990
Decision Date May 23, 1990
Days to Decision 30 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

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 962
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K901818.
BILATERAL TMJ COIL
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GE SIGNA ADVANTAGE
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MODEL 4050-21
K901864 · Medical Advances, Inc. · May 1990
MODEL 4050-64
K901639 · Medical Advances, Inc. · May 1990
VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000
K901602 · Resonex, Inc. · May 1990
MULTIPURPOSE COIL & 3MM SLICE THICKNESS ON THE MRI
K901620 · Instrumentarium Imaging, Inc. · May 1990