Cleared Traditional

K130885 - MAGNETOM AVANTO-FIT

K130885 is the FDA 510(k) clearance for MAGNETOM AVANTO-FIT 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 49-day FDA review.

K130885 · Siemens Medical Solutions USA, Inc. · Radiology device
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May 2013
Decision
49d
Days
Class 2
Risk

K130885 is an FDA 510(k) clearance for the MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Martinez, US). The FDA issued a Cleared decision on May 17, 2013 after a review of 49 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 K130885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2013
Decision Date May 17, 2013
Days to Decision 49 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
58d faster than avg
Panel avg: 107d · This submission: 49d
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 K130885.
SWIP
K131241 · Philips Medical Systems Nederland B.V. · Aug 2013
DISCOVERY MR750W 3.0T
K130115 · Ge Medical Systems, LLC · May 2013
MAGNETOM SKYRA
K123510 · Siemens Medical Solutions USA, Inc. · May 2013
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K130262 · Siemens Medical Solutions USA, Inc. · Mar 2013
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K123938 · Siemens Medical Solutions USA, Inc. · Feb 2013
VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US
K122613 · Toshiba America Medical Systems, In.C · Dec 2012