Cleared Traditional

K895966 - MAGNETOM M, H, 42, 63, 42 SP AND 63 SP (FDA 510(k) Clearance)

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

K895966 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
50d
Days
Class 2
Risk

K895966 is an FDA 510(k) clearance for the MAGNETOM M, H, 42, 63, 42 SP AND 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 November 30, 1989 after a review of 50 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 K895966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1989
Decision Date November 30, 1989
Days to Decision 50 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 107d · This submission: 50d
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 1097
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K895966.
APERTO Lucent MRI System
K253862 · Fujifilm Corporation · Apr 2026
S-scan Open (100001800)
K260746 · Esaote, S.P.A. · Mar 2026
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
K253625 · Canon Medical Systems Corporation · Mar 2026
nordicAudio (1.0)
K251937 · Nordicneurolab AS · Mar 2026
Embrace Neonatal MRI System
K254277 · Aspect Imaging, Ltd. · Mar 2026
LiverMultiScan (v6.0)
K253413 · Perspectum, Ltd. · Mar 2026