Cleared Special

GE SIGNA ASSET IMAGING OPTION (K012970) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K012970 · GE Medical Systems · Radiology device
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Sep 2001
Decision
20d
Days
Class 2
Risk

K012970 is an FDA 510(k) clearance for the GE SIGNA ASSET IMAGING OPTION. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on September 24, 2001 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K012970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2001
Decision Date September 24, 2001
Days to Decision 20 days
Submission Type Special
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
87d faster than avg
Panel avg: 107d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 498
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K012970.
INFINION 0.6T MR IMAGING SYSTEM
K013858 · Philips Medical Systems (Cleveland), Inc. · Jan 2002
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM
K012875 · GE Medical Systems · Nov 2001
OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS
K012495 · Siemens Medical Solutions USA, Inc. · Oct 2001
1.5T INFINITY TWINSPEED MR SYSTEM
K012200 · GE Medical Systems · Aug 2001
INFINION ENHANCEMENT PACKAGE
K011296 · Philips Medical Systems (Cleveland), Inc. · Jul 2001
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
K010773 · Siemens Medical Solutions USA, Inc. · May 2001