Cleared Traditional

K101347 - MAGNETOM AERA

Also marketed or referenced as:
MAGNETOM SKYRA

K101347 is an FDA 510(k) clearance for MAGNETOM AERA, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K101347 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
141d
Days
Class 2
Risk

K101347 is an FDA 510(k) clearance for the MAGNETOM AERA. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on October 1, 2010 after a review of 141 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

FDA 510(k) Submission Details - K101347

510(k) Number K101347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2010
Decision Date October 01, 2010
Days to Decision 141 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
34d slower than avg
Panel avg: 107d · This submission: 141d
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 961
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K101347.
BRIVO MR355, OPTIMA MR360
K103330 · Ge Hangwei Medical Systems Co., Ltd. · Feb 2011
MEDICAL VISORS MV100
K103507 · Medical Visors, Inc. · Feb 2011
MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS
K102344 · Philips Medical Systems Nederland B.V. · Nov 2010
MR RADIATION ONCOLOGY OPTIONS
K102155 · Ge Medical Systems, LLC · Aug 2010
MRI PATIENT POSITIONING DEVICES
K093738 · Medtec, Inc. · May 2010
3D ASL
K092925 · Ge Medical Systems, LLC · Jan 2010