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FDA 510(k) Application Details - K183204
Device Classification Name
System, X-Ray, Tomography, Computed
More FDA Info for this Device
510(K) Number
K183204
Device Name
System, X-Ray, Tomography, Computed
Applicant
GE Medical Systems SCS
283 rue de la Miniere
Buc 78530 FR
Other 510(k) Applications for this Company
Contact
Elizabeth Matthew
Other 510(k) Applications for this Contact
Regulation Number
892.1750
More FDA Info for this Regulation Number
Classification Product Code
JAK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/19/2018
Decision Date
04/08/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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