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FDA 510(k) Application Details - K170702
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K170702
Device Name
System, Image Processing, Radiological
Applicant
mediCAD Hectec Gmbh
Opalstrasse 54
Altdorf 84032 DE
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Contact
Claas-Fabian Luers
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
03/08/2017
Decision Date
09/07/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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