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510(k) K180019

CAAS Workstation by Pie Medical Imaging BV — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2018
Date Received
January 2, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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