Cleared Traditional

K993731 - SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM

K993731 is an FDA 510(k) clearance for SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM, 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 49-day FDA review.

K993731 · Siemens Medical Solutions USA, Inc. · Radiology device
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Dec 1999
Decision
49d
Days
Class 2
Risk

K993731 is an FDA 510(k) clearance for the SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM. 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 December 23, 1999 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

FDA 510(k) Submission Details - K993731

510(k) Number K993731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1999
Decision Date December 23, 1999
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.

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 K993731.
MRI EQUIPMENT COVER
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K993574 · Toshiba America Mri, Inc. · Jan 2000
MAGNETOM OPEN VIVA WITH PERMANENT MAGNET
K994316 · Siemens Medical Corp. · Jan 2000
PHILIPS EASYVISION WORKSTATION
K990329 · Philips Medical Systems North America, Inc. · Dec 1999
SIGNA HFO/I MAGNETIC RESONANCE SYSTEM
K992746 · Ge Medical Systems, Inc. · Nov 1999
INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM
K990826 · Siemens Medical Solutions USA, Inc. · Nov 1999