Cleared Traditional

K132119 - MAGNETOM PRISMA, MAGNETOM PRISMA FIT

K132119 is an FDA 510(k) clearance for MAGNETOM PRISMA, 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 136-day FDA review.

K132119 · Siemens Medical Solutions USA, Inc. · Radiology device
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Nov 2013
Decision
136d
Days
Class 2
Risk

K132119 is an FDA 510(k) clearance for the MAGNETOM PRISMA, MAGNETOM PRISMA FIT. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on November 22, 2013 after a review of 136 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 - K132119

510(k) Number K132119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2013
Decision Date November 22, 2013
Days to Decision 136 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
29d slower than avg
Panel avg: 107d · This submission: 136d
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 K132119.
HEPAFAT SCAN
K122035 · Resonance Health Analysis Services Pty, Ltd. · Dec 2013
S-SCAN
K131996 · Esaote, S.P.A. · Dec 2013
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A
K133435 · Siemens Medical Solutions USA, Inc. · Dec 2013
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T
K132376 · Ge Healthcare (Ge Medical Systems, LLC) · Nov 2013
MAGNETOM AERA
K132951 · Siemens Medical Solutions USA, Inc. · Nov 2013
QUIET/SILENT SCANNING SUITE
K132831 · Siemens Medical Solutions USA, Inc. · Nov 2013