Cleared Traditional

K940541 - MAGNETIC RESONANCE DIAG DEVICE MAGNETOM...

K940541 is the FDA 510(k) clearance for MAGNETIC RESONANCE DIAG DEVICE 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 273-day FDA review.

K940541 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
273d
Days
Class 2
Risk

K940541 is an FDA 510(k) clearance for the MAGNETIC RESONANCE DIAG DEVICE MAGNETOM VISION (MODIF). 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 7, 1994 after a review of 273 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K940541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1994
Decision Date November 07, 1994
Days to Decision 273 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 107d · This submission: 273d
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 K940541.
VERSION 5 OPERATING SYSTEM SOFTWARE
K943799 · Hitachi Medical Systems America, Inc. · Dec 1994
HEAD AND NECK COIL FOR THE GYREX 2T-DLX
K943320 · Elscint, Inc. · Nov 1994
GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE)
K940534 · Philips Medical Systems, Inc. · Nov 1994
MRT-150A
K943021 · Toshiba America Mri, Inc. · Oct 1994
QUAD PELVIS COIL
K943321 · Hitachi Medical Systems America, Inc. · Sep 1994
CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX
K934987 · Elscint, Inc. · Sep 1994