Cleared Special

1.5T INFINITY TWINSPEED MR SYSTEM (K012200) - FDA 510(k) Clearance

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

K012200 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
21d
Days
Class 2
Risk

K012200 is an FDA 510(k) clearance for the 1.5T INFINITY TWINSPEED MR SYSTEM. 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 August 3, 2001 after a review of 21 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.

View all GE Medical Systems devices

Submission Details

510(k) Number K012200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2001
Decision Date August 03, 2001
Days to Decision 21 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
86d faster than avg
Panel avg: 107d · This submission: 21d
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 K012200.
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
GE SIGNA ASSET IMAGING OPTION
K012970 · GE Medical Systems · Sep 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
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
K010691 · Philips Medical Systems (Cleveland), Inc. · May 2001