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FDA 510(k) Applications Submitted by Mary A. Mayka
FDA 510(k) Number
Submission Date
Device Name
Applicant
K171128
04/17/2017
SIGNA Premier
GE Medical Systems, LLC
K161397
05/19/2016
MAGiC
GE Medical Systems, LLC
K172695
09/07/2017
AIR Anterior Array, AIR Posterior Array
GE Healthcare Coils (USA Instruments, Inc.)
K163205
11/15/2016
48CH Head Coil
GE Healthcare Coils (USA Instruments, Inc.)
K163331
11/28/2016
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
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