Cleared Traditional

K052423 - MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION

K052423 is an FDA 510(k) clearance for MAGNETOM SYSTEMS WITH SYNGO EXPERT - I ..., manufactured by Siemens Medi Cal Solutions, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K052423 · Siemens Medi Cal Solutions, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
133d
Days
Class 2
Risk

K052423 is an FDA 510(k) clearance for the MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Siemens Medi Cal Solutions, Inc. (Mavern, US). The FDA issued a Cleared decision on January 13, 2006 after a review of 133 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 Medi Cal Solutions, Inc. devices

FDA 510(k) Submission Details - K052423

510(k) Number K052423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2005
Decision Date January 13, 2006
Days to Decision 133 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
26d slower than avg
Panel avg: 107d · This submission: 133d
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 953
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K052423.
G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004
K060956 · Esaote, S.P.A. · May 2006
ALTAIRE INTERVENTIONAL MR PACKAGE
K053309 · Hitachi Medical Systems America, Inc. · Jan 2006
EXCELART VANTAGE ZGV
K060003 · Toshibamedical Systems Corporation · Jan 2006
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K053009 · GE Medical Systems · Nov 2005
GE 1.5T SIGNA HDE MR SYSTEM
K052978 · Ge Medical Systems, LLC · Nov 2005
MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
K052164 · Siemens Medical Solutions USA, Inc. · Oct 2005