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FDA 510(k) Application Details - K172983
Device Classification Name
System, X-Ray, Tomography, Computed
More FDA Info for this Device
510(K) Number
K172983
Device Name
System, X-Ray, Tomography, Computed
Applicant
Zebra Medical Vision Ltd.
Shefayim Commercial Center
PO Box 25
Shefayim 6099000 IL
Other 510(k) Applications for this Company
Contact
Matan Neeman
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
09/27/2017
Decision Date
06/13/2018
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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