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FDA 510(k) Application Details - K163281
Device Classification Name
System, X-Ray, Tomography, Computed
More FDA Info for this Device
510(K) Number
K163281
Device Name
System, X-Ray, Tomography, Computed
Applicant
GEf Medical Systems SCS
283 rue de la Miniere
Buc 78530 FR
Other 510(k) Applications for this Company
Contact
Kristine Schraufnagel
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
11/21/2016
Decision Date
01/26/2017
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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