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U.S. Department of Health and Human Services

510(k) Premarket Notification

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61 to 70 of 84 Results
ProductCode: LNH Applicant: GE MEDICAL SYSTEMS Decision Date To: 01/22/2017
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ge 1.5t signa hde mr system GE MEDICAL SYSTEMS, LLC K052978 11/09/2005
ge 1.5t and 3.0t signa hdx mr system GE MEDICAL SYSTEMS, LLC K052293 09/21/2005
ge 0.7t signa openspeed with excite mr system GE MEDICAL SYSTEMS, LLC K032795 10/08/2003
ge 0.35t signa ovation with excite mr system GE MEDICAL SYSTEMS K053009 11/17/2005
functional brain mapping option for mri GE MEDICAL SYSTEMS K003947 03/13/2001
fiesta imaging option GE MEDICAL SYSTEMS K002997 04/11/2001
discovery mr750w 3.0t GE MEDICAL SYSTEMS, LLC K130115 05/23/2013
discovery mr750 3.0t; discovery mr750w 3.0t;discovery mr450 1.5t; discovery mr450w 1.5t; signa architect and signa artist GE Medical Systems, LLC K163331 03/17/2017
discovery mr750 3.0t, discovery mr450 1.5t, discovery mr750w 3.0t, optima mr450w 1.5t GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) K132376 11/15/2013
discovery mr750 3.0t, discovery mr450 1.5t, discovery mr750w 3.0t, optima mr450w 1.5t GE MEDICAL SYSTEMS, LLC K160618 06/09/2016
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