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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