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FDA 510(k) Application Details - K202487
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K202487
Device Name
System, Image Processing, Radiological
Applicant
Zebra Medical Vision Ltd.
Shefayim Commercial Center
PO Box 25
Shefayim 6099000 IL
Other 510(k) Applications for this Company
Contact
Flair Bar
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/31/2020
Decision Date
12/04/2020
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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