Cleared Traditional

K901818 - ADD'L SOFTWARE VERSION D2 FOR MAGNETOM ...

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

K901818 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 812
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K901818.
KNEE QD COIL MRT 50A
K902316 · Toshiba America Mri, Inc. · Aug 1990
GE SIGNA ADVANTAGE
K901730 · GE Medical Systems · Jul 1990
MODEL 4050-21
K901864 · Medical Advances, Inc. · May 1990
MODEL 4050-64
K901639 · Medical Advances, Inc. · May 1990
MODEL 2121-64
K901242 · Medical Advances, Inc. · Apr 1990
MODEL 2121-21, TMJ SURFACE COIL
K901305 · Medical Advances, Inc. · Apr 1990