Cleared Traditional

K883898 - MAGNETOM 42 SP AND MAGNETOM 63 SP

K883898 is the FDA 510(k) clearance for MAGNETOM 42 SP AND MAGNETOM 63 SP 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 131-day FDA review.

K883898 · Siemens Medical Solutions USA, Inc. · Radiology device
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Jan 1989
Decision
131d
Days
Class 2
Risk

K883898 is an FDA 510(k) clearance for the MAGNETOM 42 SP AND MAGNETOM 63 SP. 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 January 24, 1989 after a review of 131 days - within the typical 510(k) review window.

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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K883898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1988
Decision Date January 24, 1989
Days to Decision 131 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 107d · This submission: 131d
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 K883898.
VISTA MR 2055 HP SYSTEM
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MEDRAD SCPD 1000
K890394 · Medrad, Inc. · Mar 1989
ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY
K884816 · Diasonics, Inc. · Feb 1989
MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL
K884484 · Siemens Medical Solutions USA, Inc. · Jan 1989
MT/S (SOFTWARE RELEASE 3.1)
K884607 · Diasonics, Inc. · Dec 1988
MT/S (SPINE TRANSMIT COIL)
K884606 · Diasonics, Inc. · Dec 1988