Cleared Traditional

K043030 - MAGNETOM C! MR SYSTEM

K043030 is an FDA 510(k) clearance for MAGNETOM C! MR SYSTEM, manufactured by Siemens Medical Solutions. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K043030 · Siemens Medical Solutions · Radiology device
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Dec 2004
Decision
36d
Days
Class 2
Risk

K043030 is an FDA 510(k) clearance for the MAGNETOM C! MR SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Siemens Medical Solutions (Malvern, US). The FDA issued a Cleared decision on December 9, 2004 after a review of 36 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 devices

FDA 510(k) Submission Details - K043030

510(k) Number K043030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2004
Decision Date December 09, 2004
Days to Decision 36 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 107d · This submission: 36d
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 841
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K043030.
MAGNETOM TRIO A TIM SYSTEM
K050200 · Siemens Medical Solutions USA, Inc. · Feb 2005
ACHIEVA FAMILY
K043147 · Philips Medical Systems North America Co. · Feb 2005
GE SIGNA EXCITE MR SURGICAL OPTION
K043262 · Ge Healthcare · Jan 2005
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM
K043112 · General Electric Co. · Nov 2004
G-SCAN
K042236 · Esaote, S.P.A. · Oct 2004
PANORAMA 1.0T
K041602 · Philips Medical Systems North America, Inc. · Jul 2004