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510(k) K203187

HiRise by Curvebeam, LLC — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2020
Date Received
October 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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