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FDA 510(k) Applications Submitted by GE Healthcare (GE Medical Systems, LLC)
FDA 510(k) Number
Submission Date
Device Name
Applicant
K202966
09/30/2020
SIGNA Architect
GE Healthcare (GE Medical Systems, LLC)
K193282
11/27/2019
SIGNA Premier
GE Healthcare (GE Medical Systems, LLC)
K132376
07/30/2013
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC)
K123522
11/15/2012
OPTIMA MR450W
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC)
K213668
11/22/2021
SIGNA Hero
GE Healthcare (GE Medical Systems, LLC)
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