Cleared Traditional

K971684 - MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3....

K971684 is the FDA 510(k) clearance for MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.... 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 90-day FDA review.

K971684 · Siemens Medical Solutions USA, Inc. · Radiology device
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Aug 1997
Decision
90d
Days
Class 2
Risk

K971684 is an FDA 510(k) clearance for the MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE). Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on August 5, 1997 after a review of 90 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

Submission Details

510(k) Number K971684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1997
Decision Date August 05, 1997
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 K971684.
CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT
K973799 · Siemens Medical Solutions USA, Inc. · Jan 1998
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ASSET APOLLO
K971884 · Philips Medical Systems (Cleveland), Inc. · Aug 1997
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K970573 · Toshiba America Mri, Inc. · Jul 1997
MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE
K965068 · Toshiba America Medical Systems, In.C · Jul 1997